naproxen Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
1883 22204-53-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methoxypropiocin
  • naproxen
  • naprosyn
  • aproxen
  • naproxen sodium
  • aleve
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
  • Molecular weight: 230.26
  • Formula: C14H14O3
  • CLOGP: 2.82
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -3.65
  • ROTB: 3

Drug dosage:

DoseUnitRoute
0.50 g O
0.50 g R
0.50 g O

Approvals:

DateAgencyCompanyOrphan
March 11, 1976 FDA ROCHE PALO

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 2936.66 27.83 1050 9926 67350 4560666
Completed suicide 2241.84 27.83 763 10213 41682 4586334
Drug ineffective 1640.85 27.83 947 10029 185114 4442902
Acute kidney injury 1468.70 27.83 645 10331 69786 4558230
Toxicity to various agents 1402.99 27.83 629 10347 71411 4556605
Gastrointestinal haemorrhage 1402.09 27.83 496 10480 30039 4597977
Nausea 1083.11 27.83 717 10259 176616 4451400
Dizziness 1003.69 27.83 557 10419 99314 4528702
Vomiting 959.17 27.83 576 10400 119123 4508893
Pain 886.03 27.83 501 10475 92369 4535647
Pharyngitis 874.11 27.83 214 10762 3425 4624591
Synovitis 805.22 27.83 200 10776 3405 4624611
Gastric ulcer 781.97 27.83 218 10758 5905 4622111
Haematemesis 778.58 27.83 237 10739 8806 4619210
Gastric haemorrhage 770.49 27.83 200 10776 4094 4623922
Rheumatoid arthritis 763.96 27.83 302 10674 24697 4603319
Rash 738.03 27.83 471 10505 107917 4520099
Abdominal discomfort 686.21 27.83 290 10686 28118 4599898
Melaena 681.45 27.83 219 10757 9739 4618277
Haemoglobin decreased 666.60 27.83 309 10667 37348 4590668
Arthralgia 665.72 27.83 399 10577 81595 4546421
Upper gastrointestinal haemorrhage 664.07 27.83 188 10788 5385 4622631
Duodenal ulcer 630.88 27.83 160 10816 2970 4625046
Abdominal pain upper 630.29 27.83 291 10685 34824 4593192
Abdominal pain 617.34 27.83 341 10635 59683 4568333
Arthropathy 598.14 27.83 202 10774 10496 4617520
Headache 594.68 27.83 432 10544 121941 4506075
Drug intolerance 592.30 27.83 242 10734 21504 4606512
Condition aggravated 588.58 27.83 327 10649 57844 4570172
Ear infection 522.44 27.83 152 10824 4801 4623215
Intentional overdose 511.16 27.83 218 10758 21548 4606468
Deafness transitory 504.69 27.83 87 10889 176 4627840
Overdose 484.70 27.83 261 10715 43298 4584718
Pain in extremity 459.53 27.83 288 10688 63451 4564565
Gastrointestinal pain 459.47 27.83 111 10865 1667 4626349
Weight decreased 445.91 27.83 267 10709 54197 4573819
Contraindicated product administered 438.61 27.83 134 10842 5017 4622999
Dyspnoea 436.48 27.83 380 10596 138605 4489411
Urticaria 431.40 27.83 234 10742 39339 4588677
C-reactive protein abnormal 429.31 27.83 96 10880 1004 4627012
Decreased appetite 421.93 27.83 261 10715 56136 4571880
Fatigue 421.27 27.83 380 10596 145186 4482830
Faeces discoloured 417.73 27.83 129 10847 5008 4623008
Anaemia 414.62 27.83 282 10694 71278 4556738
Respiratory arrest 412.21 27.83 163 10813 13257 4614759
Hypotension 410.53 27.83 274 10702 67126 4560890
Red blood cell sedimentation rate abnormal 409.24 27.83 84 10892 560 4627456
Anaphylactic reaction 405.84 27.83 175 10801 17735 4610281
Joint swelling 404.91 27.83 191 10785 23887 4604129
Gastritis 404.44 27.83 141 10835 8045 4619971
Suicide attempt 380.38 27.83 175 10801 20667 4607349
Angioedema 363.94 27.83 167 10809 19598 4608418
Cardiac arrest 361.86 27.83 198 10778 33809 4594207
Diarrhoea 348.14 27.83 347 10629 149838 4478178
Pruritus 332.46 27.83 248 10728 72324 4555692
Human antichimeric antibody positive 331.15 27.83 51 10925 26 4627990
Peripheral swelling 327.70 27.83 171 10805 26521 4601495
Shoulder arthroplasty 326.32 27.83 67 10909 447 4627569
Osteoporosis 325.10 27.83 113 10863 6382 4621634
Malaise 311.71 27.83 261 10715 89896 4538120
Duodenal ulcer haemorrhage 306.60 27.83 75 10901 1188 4626828
Musculoskeletal stiffness 302.48 27.83 145 10831 18757 4609259
Body height below normal 296.13 27.83 55 10921 197 4627819
Haematochezia 293.48 27.83 121 10855 10943 4617073
Infection 292.21 27.83 176 10800 35966 4592050
Hypersensitivity 287.35 27.83 178 10798 38243 4589773
Gastrointestinal disorder 283.97 27.83 132 10844 15929 4612087
Musculoskeletal pain 270.70 27.83 129 10847 16459 4611557
Swelling 269.80 27.83 146 10830 24336 4603680
Deafness 269.66 27.83 93 10883 5126 4622890
Ulcer 268.56 27.83 83 10893 3224 4624792
Adrenal insufficiency 266.85 27.83 81 10895 2959 4625057
Toothache 265.27 27.83 85 10891 3721 4624295
Gastric ulcer haemorrhage 264.34 27.83 73 10903 1895 4626121
Hypoaesthesia 263.16 27.83 157 10819 31508 4596508
Hypophagia 262.08 27.83 101 10875 7647 4620369
Loss of personal independence in daily activities 261.19 27.83 102 10874 8003 4620013
Somnolence 259.29 27.83 175 10801 43485 4584531
Drug interaction 259.08 27.83 204 10772 64304 4563712
Impaired work ability 258.82 27.83 79 10897 2941 4625075
Rectal haemorrhage 258.33 27.83 114 10862 12182 4615834
C-reactive protein increased 257.02 27.83 115 10861 12697 4615319
Dyspepsia 247.25 27.83 120 10856 15934 4612082
Swelling face 246.99 27.83 117 10859 14723 4613293
Haematocrit decreased 244.18 27.83 100 10876 8882 4619134
Therapeutic product effect decreased 241.10 27.83 124 10852 18629 4609387
Lip swelling 239.31 27.83 96 10880 8083 4619933
Polyarthritis 238.40 27.83 64 10912 1489 4626527
Cardio-respiratory arrest 237.46 27.83 125 10851 19697 4608319
Asthenia 234.60 27.83 218 10758 85945 4542071
Obesity 230.21 27.83 71 10905 2737 4625279
Juvenile idiopathic arthritis 229.63 27.83 54 10922 716 4627300
Femur fracture 228.48 27.83 94 10882 8445 4619571
Gastritis erosive 227.98 27.83 65 10911 1900 4626116
Fall 227.12 27.83 205 10771 77841 4550175
Metabolic acidosis 225.31 27.83 104 10872 12336 4615680
Lower respiratory tract infection 223.92 27.83 97 10879 9906 4618110
Erythema 222.79 27.83 157 10819 41783 4586233
Renal failure 222.40 27.83 156 10820 41213 4586803
Synovial fluid analysis 219.88 27.83 33 10943 9 4628007
Wheezing 210.45 27.83 96 10880 11078 4616938
Flank pain 207.76 27.83 65 10911 2628 4625388
Hyperkalaemia 207.24 27.83 106 10870 15731 4612285
Tubulointerstitial nephritis 204.18 27.83 79 10897 6040 4621976
Blood creatinine increased 199.34 27.83 124 10852 26776 4601240
Foot operation 199.03 27.83 50 10926 887 4627129
Toxic epidermal necrolysis 192.68 27.83 76 10900 6116 4621900
Tenosynovitis stenosans 191.27 27.83 36 10940 141 4627875
Feeding disorder 187.05 27.83 59 10917 2450 4625566
Poisoning 184.75 27.83 73 10903 5901 4622115
Stevens-Johnson syndrome 181.08 27.83 80 10896 8559 4619457
Bone density decreased 178.25 27.83 53 10923 1800 4626216
Chest pain 177.24 27.83 148 10828 50552 4577464
Fibromyalgia 174.32 27.83 62 10914 3739 4624277
Arthritis 173.99 27.83 92 10884 14608 4613408
Nephrolithiasis 171.26 27.83 78 10898 8961 4619055
Red blood cell sedimentation rate increased 170.26 27.83 59 10917 3294 4624722
Loss of consciousness 169.78 27.83 125 10851 35557 4592459
Back pain 169.24 27.83 144 10832 50455 4577561
Joint laxity 165.74 27.83 28 10948 47 4627969
Paraesthesia 162.49 27.83 121 10855 35012 4593004
Product use issue 162.07 27.83 106 10870 24930 4603086
Insomnia 161.85 27.83 134 10842 45211 4582805
Nerve injury 160.92 27.83 48 10928 1648 4626368
Musculoskeletal disorder 159.38 27.83 58 10918 3737 4624279
Chronic kidney disease 159.10 27.83 78 10898 10567 4617449
Atrial fibrillation 159.05 27.83 114 10862 31101 4596915
Scleritis 156.52 27.83 36 10940 430 4627586
Mouth ulceration 155.36 27.83 65 10911 6085 4621931
Tachycardia 154.70 27.83 112 10864 31033 4596983
Disability 154.07 27.83 45 10931 1434 4626582
Constipation 153.41 27.83 126 10850 42028 4585988
Milk-alkali syndrome 152.10 27.83 31 10945 198 4627818
Rheumatoid nodule 150.58 27.83 39 10937 785 4627231
Blood pressure increased 148.73 27.83 107 10869 29353 4598663
Synovial cyst 148.48 27.83 42 10934 1191 4626825
Gastrooesophageal reflux disease 147.91 27.83 83 10893 14810 4613206
Gait inability 147.83 27.83 72 10904 9613 4618403
Muscle spasms 145.99 27.83 114 10862 35376 4592640
Joint effusion 145.65 27.83 46 10930 1917 4626099
Off label use 145.48 27.83 207 10769 128906 4499110
Gastric disorder 144.67 27.83 61 10915 5821 4622195
Crepitations 143.94 27.83 41 10935 1193 4626823
Cushingoid 143.21 27.83 40 10936 1082 4626934
Occult blood positive 142.07 27.83 40 10936 1115 4626901
Tenderness 140.59 27.83 50 10926 3013 4625003
Swollen tongue 139.43 27.83 67 10909 8683 4619333
Pallor 139.06 27.83 64 10912 7528 4620488
Diverticulitis 137.16 27.83 62 10914 6995 4621021
Accidental exposure to product by child 136.33 27.83 42 10934 1611 4626405
Haemorrhage 136.29 27.83 96 10880 25466 4602550
Pseudoporphyria 135.84 27.83 27 10949 149 4627867
Red blood cell count decreased 130.55 27.83 63 10913 8240 4619776
Depression 130.02 27.83 121 10855 47612 4580404
Antibody test positive 129.02 27.83 32 10944 537 4627479
Hiatus hernia 128.39 27.83 48 10928 3336 4624680
Pleuritic pain 128.08 27.83 37 10939 1133 4626883
Dry mouth 127.34 27.83 72 10904 13029 4614987
Bursitis 127.15 27.83 45 10931 2673 4625343
Peptic ulcer 126.91 27.83 37 10939 1171 4626845
Death 126.50 27.83 246 10730 197917 4430099
Hypersensitivity vasculitis 124.02 27.83 44 10932 2632 4625384
Oesophageal ulcer 123.58 27.83 38 10938 1448 4626568
Feeling jittery 122.46 27.83 45 10931 2979 4625037
Confusional state 121.97 27.83 118 10858 48716 4579300
Pneumonia 121.86 27.83 169 10807 102646 4525370
Intentional product misuse 121.35 27.83 79 10897 18414 4609602
Antinuclear antibody positive 120.90 27.83 38 10938 1558 4626458
Impaired healing 120.35 27.83 60 10916 8419 4619597
Hypertension 119.89 27.83 119 10857 50679 4577337
Mobility decreased 118.78 27.83 69 10907 13136 4614880
Adverse reaction 117.99 27.83 42 10934 2537 4625479
Foot deformity 117.61 27.83 42 10934 2561 4625455
Pyrexia 116.48 27.83 169 10807 106975 4521041
Hyperhidrosis 116.33 27.83 93 10883 29824 4598192
Oesophagitis 116.12 27.83 47 10929 4041 4623975
Functional gastrointestinal disorder 116.03 27.83 32 10944 825 4627191
Septic shock 113.39 27.83 73 10903 16693 4611323
Iron deficiency anaemia 113.35 27.83 44 10932 3388 4624628
International normalised ratio increased 112.51 27.83 73 10903 16915 4611101
Syncope 111.45 27.83 95 10881 33300 4594716
Ocular hyperaemia 110.82 27.83 52 10924 6388 4621628
Kounis syndrome 109.84 27.83 30 10946 745 4627271
Photophobia 109.39 27.83 44 10932 3722 4624294
Cough 109.16 27.83 118 10858 55469 4572547
Duodenal ulcer perforation 108.71 27.83 29 10947 657 4627359
Joint destruction 108.42 27.83 27 10949 461 4627555
Epistaxis 107.54 27.83 75 10901 19568 4608448
Chest discomfort 107.37 27.83 80 10896 23130 4604886
Heart rate increased 106.69 27.83 73 10903 18469 4609547
Conjunctivitis 105.89 27.83 45 10931 4375 4623641
Incorrect dosage administered 103.99 27.83 28 10948 658 4627358
Visual impairment 103.50 27.83 73 10903 19387 4608629
Intestinal ulcer 103.48 27.83 26 10950 461 4627555
Blood urea increased 101.33 27.83 54 10922 8696 4619320
Extra dose administered 100.96 27.83 36 10940 2185 4625831
Nodule 100.76 27.83 40 10936 3269 4624747
Renal tubular necrosis 99.90 27.83 42 10934 3976 4624040
Urinary retention 98.06 27.83 55 10921 9792 4618224
Acne cystic 97.50 27.83 21 10955 181 4627835
Atelectasis 96.01 27.83 41 10935 4034 4623982
Duodenitis 95.68 27.83 30 10946 1220 4626796
Drug eruption 94.51 27.83 47 10929 6556 4621460
Loose body in joint 92.84 27.83 17 10959 55 4627961
Gastrointestinal ulcer 91.98 27.83 26 10950 735 4627281
Oedema peripheral 91.07 27.83 94 10882 41878 4586138
Blood loss anaemia 90.66 27.83 33 10943 2125 4625891
Eye pain 90.41 27.83 48 10928 7669 4620347
Intestinal diaphragm disease 90.00 27.83 18 10958 103 4627913
Palpitations 89.73 27.83 74 10902 24772 4603244
Wheelchair user 88.60 27.83 25 10951 702 4627314
Intestinal perforation 87.35 27.83 38 10938 3910 4624106
Dry eye 87.25 27.83 42 10934 5459 4622557
Anaphylactic shock 86.80 27.83 47 10929 7810 4620206
Glomerulonephritis membranous 85.68 27.83 22 10954 427 4627589
Vision blurred 85.68 27.83 72 10904 24731 4603285
Bone disorder 85.59 27.83 40 10936 4867 4623149
Serotonin syndrome 85.24 27.83 45 10931 7107 4620909
Serum sickness-like reaction 85.05 27.83 19 10957 197 4627819
Ankylosing spondylitis 84.28 27.83 29 10947 1583 4626433
Drug specific antibody 81.16 27.83 18 10958 180 4627836
Rash pruritic 81.06 27.83 53 10923 12430 4615586
Depressed level of consciousness 80.92 27.83 57 10919 15097 4612919
Eye irritation 80.25 27.83 39 10937 5175 4622841
Eye swelling 79.43 27.83 42 10934 6655 4621361
Fixed eruption 79.21 27.83 21 10955 464 4627552
Hepatic enzyme increased 76.52 27.83 59 10917 17932 4610084
Urinary tract infection 76.27 27.83 86 10890 42304 4585712
Multiple fractures 75.70 27.83 24 10952 1012 4627004
Muscular weakness 75.50 27.83 69 10907 26481 4601535
Renal impairment 74.30 27.83 67 10909 25271 4602745
Asthma 73.95 27.83 57 10919 17317 4610699
Metabolic alkalosis 73.12 27.83 21 10955 629 4627387
Pulmonary oedema 72.30 27.83 53 10923 14933 4613083
Haematuria 72.08 27.83 50 10926 12920 4615096
Dehydration 71.35 27.83 83 10893 42207 4585809
Pulmonary congestion 71.25 27.83 33 10943 3933 4624083
Suicidal ideation 71.15 27.83 61 10915 21522 4606494
Depressed mood 71.11 27.83 43 10933 8801 4619215
Hypercalcaemia 70.22 27.83 35 10941 4903 4623113
Lethargy 69.98 27.83 55 10921 17186 4610830
Hyponatraemia 69.78 27.83 64 10912 24666 4603350
Abnormal loss of weight 69.65 27.83 24 10952 1315 4626701
Tremor 69.41 27.83 76 10900 36183 4591833
Anxiety 69.21 27.83 87 10889 47924 4580092
Coma 69.20 27.83 55 10921 17464 4610552
Leukocytosis 68.91 27.83 40 10936 7594 4620422
Contusion 68.77 27.83 57 10919 19201 4608815
Drug abuse 68.69 27.83 67 10909 27880 4600136
Flushing 68.53 27.83 57 10919 19295 4608721
Multiple organ dysfunction syndrome 67.99 27.83 56 10920 18700 4609316
Feeling abnormal 67.43 27.83 75 10901 36330 4591686
Medication error 67.33 27.83 50 10926 14366 4613650
Weight increased 67.13 27.83 75 10901 36506 4591510
Mental status changes 67.11 27.83 47 10929 12329 4615687
Agitation 67.06 27.83 62 10914 24138 4603878
Osteoporotic fracture 66.78 27.83 19 10957 550 4627466
Diverticulum 66.00 27.83 28 10948 2709 4625307
Unresponsive to stimuli 65.89 27.83 43 10933 10050 4617966
Small intestinal haemorrhage 65.88 27.83 20 10956 729 4627287
Blister 65.44 27.83 45 10931 11464 4616552
Sacroiliitis 64.82 27.83 18 10958 476 4627540
Interstitial lung disease 64.57 27.83 55 10921 19230 4608786
Poisoning deliberate 64.21 27.83 26 10950 2236 4625780
Abdominal distension 63.72 27.83 53 10923 17936 4610080
Sedation 63.28 27.83 38 10938 7679 4620337
Proteinuria 63.18 27.83 36 10940 6600 4621416
Therapeutic response decreased 62.78 27.83 48 10928 14403 4613613
Psoriasis 62.39 27.83 66 10910 30218 4597798
Ulcer haemorrhage 62.24 27.83 21 10955 1079 4626937
Liver function test abnormal 62.08 27.83 48 10928 14644 4613372
Adverse drug reaction 61.94 27.83 48 10928 14691 4613325
Large intestinal ulcer 61.85 27.83 20 10956 899 4627117
Bunion operation 60.80 27.83 14 10962 168 4627848
Abdominal transposition 60.71 27.83 10 10966 13 4628003
Thrombosis 60.62 27.83 52 10924 18352 4609664
Electrocardiogram QT prolonged 60.37 27.83 48 10928 15247 4612769
Back disorder 60.14 27.83 26 10950 2634 4625382
Neoplasm malignant 60.10 27.83 42 10934 10979 4617037
Colitis ischaemic 59.45 27.83 26 10950 2709 4625307
Throat tightness 58.78 27.83 34 10942 6412 4621604
Pharyngeal oedema 58.31 27.83 32 10944 5457 4622559
Osteoarthritis 58.05 27.83 39 10937 9565 4618451
Lung disorder 57.97 27.83 43 10933 12328 4615688
Foetal exposure during pregnancy 57.78 27.83 56 10920 23113 4604903
Throat irritation 57.69 27.83 35 10941 7203 4620813
Dermatitis bullous 57.58 27.83 26 10950 2921 4625095
Tinnitus 57.40 27.83 38 10938 9095 4618921
Burning sensation 57.29 27.83 42 10934 11830 4616186
Peptic ulcer perforation 57.19 27.83 12 10964 90 4627926
Steatorrhoea 56.89 27.83 14 10962 227 4627789
Expired product administered 56.36 27.83 24 10952 2343 4625673
Dyspnoea exertional 55.67 27.83 39 10937 10233 4617783
Gastrointestinal sounds abnormal 55.21 27.83 19 10957 1037 4626979
Dysphagia 55.01 27.83 57 10919 25474 4602542
Bezoar 54.55 27.83 15 10961 382 4627634
Sinus tachycardia 54.51 27.83 32 10944 6202 4621814
Intentional self-injury 54.51 27.83 34 10942 7349 4620667
Periorbital oedema 54.34 27.83 22 10954 1891 4626125
End stage renal disease 54.25 27.83 21 10955 1603 4626413
Hand deformity 54.00 27.83 20 10956 1352 4626664
Rhabdomyolysis 53.97 27.83 50 10926 19508 4608508
Heart rate decreased 53.79 27.83 33 10943 6927 4621089
Angina pectoris 53.38 27.83 37 10939 9544 4618472
Respiratory tract congestion 52.54 27.83 26 10950 3585 4624431
Myalgia 52.49 27.83 71 10905 41977 4586039
Face oedema 52.42 27.83 32 10944 6658 4621358
Therapy non-responder 52.33 27.83 45 10931 15932 4612084
Migraine 51.92 27.83 42 10934 13667 4614349
Tongue oedema 51.15 27.83 20 10956 1569 4626447
Infusion related reaction 50.69 27.83 47 10929 18355 4609661
Gait disturbance 50.57 27.83 65 10911 36575 4591441
Failure of child resistant mechanism for pharmaceutical product 50.49 27.83 10 10966 54 4627962
Rash erythematous 50.30 27.83 37 10939 10472 4617544
Joint range of motion decreased 49.89 27.83 23 10953 2711 4625305
Balance disorder 49.65 27.83 44 10932 16212 4611804
Immunodeficiency 49.44 27.83 20 10956 1715 4626301
Neck pain 49.36 27.83 38 10938 11514 4616502
Pain in jaw 49.30 27.83 34 10942 8698 4619318
Inflammation 49.11 27.83 36 10940 10135 4617881
Drug reaction with eosinophilia and systemic symptoms 48.89 27.83 38 10938 11675 4616341
Purpura 48.44 27.83 25 10951 3767 4624249
Neck mass 48.04 27.83 15 10961 601 4627415
Diverticular perforation 47.83 27.83 17 10959 1021 4626995
Therapeutic product effect incomplete 47.49 27.83 44 10932 17164 4610852
Skin exfoliation 46.93 27.83 36 10940 10851 4617165
Gastrointestinal fistula 46.58 27.83 12 10964 236 4627780
Gangrene neonatal 46.56 27.83 7 10969 2 4628014
Presyncope 46.26 27.83 30 10946 6934 4621082
Oedema 46.14 27.83 45 10931 18706 4609310
Thrombocytosis 46.04 27.83 19 10957 1715 4626301
Immune thrombocytopenic purpura 45.96 27.83 23 10953 3249 4624767
Abdominal tenderness 45.89 27.83 19 10957 1729 4626287
Acute myocardial infarction 45.88 27.83 40 10936 14419 4613597
Amnesia 45.61 27.83 38 10938 12883 4615133
Haemodialysis 45.15 27.83 26 10950 4861 4623155
Intestinal obstruction 45.03 27.83 32 10944 8585 4619431
Product use in unapproved indication 44.95 27.83 51 10925 25222 4602794
Erosive duodenitis 44.93 27.83 13 10963 400 4627616
Incorrect dose administered 44.88 27.83 45 10931 19340 4608676
Pleural effusion 44.70 27.83 50 10926 24348 4603668
Cellulitis 44.67 27.83 42 10934 16690 4611326
Gastritis haemorrhagic 44.60 27.83 14 10962 571 4627445
Dysuria 44.43 27.83 31 10945 8079 4619937
Pericardial haemorrhage 44.25 27.83 16 10960 1010 4627006
Meningitis aseptic 43.65 27.83 17 10959 1319 4626697
Lower gastrointestinal haemorrhage 43.59 27.83 20 10956 2331 4625685
Eyelid oedema 43.28 27.83 24 10952 4175 4623841
Gastric ulcer perforation 43.24 27.83 13 10963 458 4627558
Nervousness 43.19 27.83 30 10946 7762 4620254
Tachypnoea 42.39 27.83 25 10951 4886 4623130
Quality of life decreased 42.35 27.83 17 10959 1429 4626587
Hot flush 42.16 27.83 33 10943 10242 4617774
Microcytic anaemia 41.87 27.83 15 10961 922 4627094
Shock 41.79 27.83 31 10945 8885 4619131
Discomfort 41.65 27.83 30 10946 8220 4619796
Oropharyngeal pain 41.56 27.83 41 10935 17278 4610738
Obstructive airways disorder 41.52 27.83 20 10956 2600 4625416
Eosinophilia 41.30 27.83 28 10948 6965 4621051
Photosensitivity reaction 41.11 27.83 24 10952 4602 4623414
Dysarthria 40.92 27.83 35 10941 12297 4615719
Suicidal behaviour 40.87 27.83 15 10961 988 4627028
Vertigo 40.80 27.83 38 10938 14918 4613098
Blood pressure decreased 40.43 27.83 41 10935 17859 4610157
Seizure 40.21 27.83 69 10907 50168 4577848
Blood pressure systolic increased 40.01 27.83 23 10953 4285 4623731
Gastric perforation 39.89 27.83 14 10962 810 4627206
Glomerular filtration rate decreased 39.83 27.83 21 10955 3305 4624711
Myocardial infarction 39.76 27.83 68 10908 49308 4578708
Miosis 39.66 27.83 20 10956 2870 4625146
Petechiae 39.24 27.83 22 10954 3909 4624107
Peritonitis 39.17 27.83 25 10951 5620 4622396
Respiratory failure 39.04 27.83 52 10924 30274 4597742
Anti-transglutaminase antibody 38.99 27.83 6 10970 3 4628013
Blood potassium increased 38.97 27.83 24 10952 5071 4622945
Analgesic drug level increased 38.84 27.83 12 10964 464 4627552
Hypokalaemia 38.82 27.83 41 10935 18719 4609297
Alcohol use 38.79 27.83 16 10960 1442 4626574
Haemorrhoids 38.61 27.83 23 10953 4578 4623438
Drug-induced liver injury 38.33 27.83 29 10947 8562 4619454
Aspirin-exacerbated respiratory disease 38.03 27.83 11 10965 338 4627678
Nasopharyngitis 37.93 27.83 54 10922 33463 4594553
Discoloured vomit 37.80 27.83 9 10967 126 4627890
Hypoglycaemia 37.68 27.83 40 10936 18369 4609647
Mydriasis 37.27 27.83 21 10955 3767 4624249
Lip oedema 37.20 27.83 16 10960 1600 4626416
Hepatic failure 37.01 27.83 34 10942 13115 4614901
Shock haemorrhagic 36.87 27.83 19 10957 2853 4625163
Oxygen saturation decreased 36.84 27.83 35 10941 14086 4613930
Blood pressure fluctuation 36.75 27.83 21 10955 3869 4624147
Disorientation 36.61 27.83 33 10943 12426 4615590
Jaundice 36.57 27.83 33 10943 12441 4615575
Transient ischaemic attack 36.57 27.83 32 10944 11590 4616426
Respiratory rate increased 36.55 27.83 19 10957 2904 4625112
Fracture 36.51 27.83 22 10954 4471 4623545
Meningocele 36.25 27.83 8 10968 78 4627938
Eye disorder 36.12 27.83 23 10953 5151 4622865
Helicobacter test positive 35.99 27.83 10 10966 265 4627751
Treatment noncompliance 35.62 27.83 32 10944 11995 4616021
Urine output decreased 35.29 27.83 19 10957 3118 4624898
Coordination abnormal 35.11 27.83 20 10956 3662 4624354
Disseminated intravascular coagulation 35.06 27.83 26 10950 7447 4620569
Congenital cardiovascular anomaly 34.90 27.83 10 10966 297 4627719
Gastroenteritis viral 34.82 27.83 20 10956 3720 4624296
Blood disorder 34.71 27.83 16 10960 1885 4626131
Paraesthesia oral 34.62 27.83 19 10957 3239 4624777
Blood bilirubin increased 34.23 27.83 32 10944 12620 4615396
Smear cervix abnormal 34.03 27.83 10 10966 325 4627691
Oedema mouth 34.03 27.83 14 10962 1253 4626763
Renal disorder 33.92 27.83 28 10948 9368 4618648
Respiratory depression 33.90 27.83 22 10954 5088 4622928
Knee arthroplasty 33.62 27.83 20 10956 3969 4624047
Spinal pain 33.33 27.83 16 10960 2065 4625951
Mucosal inflammation 33.24 27.83 30 10946 11313 4616703
Bronchitis 33.21 27.83 39 10937 20001 4608015
Blood albumin decreased 32.78 27.83 19 10957 3595 4624421
Speech disorder 32.74 27.83 30 10946 11532 4616484
White blood cell count increased 32.72 27.83 34 10942 15233 4612783
Alanine aminotransferase increased 32.52 27.83 46 10930 28327 4599689
Diverticulum intestinal haemorrhagic 32.38 27.83 11 10965 577 4627439
Eating disorder 32.27 27.83 19 10957 3701 4624315
Chills 31.95 27.83 46 10930 28793 4599223
Analgesic drug level above therapeutic 31.84 27.83 7 10969 67 4627949
Serum ferritin abnormal 31.84 27.83 7 10969 67 4627949
Blood calcium decreased 31.66 27.83 19 10957 3832 4624184
Rash macular 31.60 27.83 22 10954 5710 4622306
Cardiovascular disorder 31.58 27.83 22 10954 5718 4622298
Ecchymosis 31.57 27.83 17 10959 2790 4625226
Weight decrease neonatal 31.56 27.83 7 10969 70 4627946
Cholestasis 31.55 27.83 25 10951 7895 4620121
Skin discolouration 31.51 27.83 26 10950 8692 4619324
Sleep apnoea syndrome 31.36 27.83 20 10956 4491 4623525
Feeling hot 31.31 27.83 28 10948 10433 4617583
Blood pressure systolic decreased 31.19 27.83 14 10962 1550 4626466
Hydronephrosis 31.11 27.83 17 10959 2872 4625144
Carpal tunnel syndrome 31.03 27.83 17 10959 2887 4625129
Movement disorder 30.30 27.83 20 10956 4759 4623257
Gastroduodenal ulcer 30.16 27.83 8 10968 177 4627839
Coagulopathy 30.11 27.83 22 10954 6158 4621858
Thirst 30.01 27.83 17 10959 3079 4624937
Gastrointestinal ulcer haemorrhage 29.99 27.83 9 10967 315 4627701
Platelet count increased 29.89 27.83 19 10957 4241 4623775
Haemophagocytic lymphohistiocytosis 29.70 27.83 17 10959 3142 4624874
Hypovolaemia 29.65 27.83 16 10960 2637 4625379
Blood pH decreased 29.52 27.83 12 10964 1042 4626974
Hepatocellular injury 29.48 27.83 24 10952 7876 4620140
Blood cholesterol increased 29.47 27.83 25 10951 8681 4619335
Aspartate aminotransferase increased 29.43 27.83 41 10935 24897 4603119
Disturbance in attention 29.08 27.83 27 10949 10554 4617462
Cerebral haemorrhage 28.92 27.83 30 10946 13411 4614605
Nephrotic syndrome 28.72 27.83 16 10960 2807 4625209
Exposure during pregnancy 28.65 27.83 47 10929 32924 4595092
Hallucination 28.64 27.83 34 10942 17634 4610382
Alopecia 28.52 27.83 43 10933 28037 4599979
Acidosis 28.51 27.83 17 10959 3389 4624627
Livedo reticularis 28.40 27.83 11 10965 841 4627175
Blood iron decreased 28.39 27.83 14 10962 1915 4626101
Abnormal faeces 28.35 27.83 12 10964 1154 4626862
Eosinophilic pneumonia 28.19 27.83 12 10964 1170 4626846
Mucosal dryness 28.16 27.83 10 10966 599 4627417
Hepatorenal syndrome 28.08 27.83 11 10965 867 4627149
Cardiac failure 28.02 27.83 42 10934 27246 4600770
Respiratory distress 27.95 27.83 27 10949 11089 4616927
Limb deformity 27.88 27.83 9 10967 402 4627614
Hepatitis acute 27.85 27.83 16 10960 2976 4625040
Nephropathy toxic 27.85 27.83 18 10958 4134 4623882

Pharmacologic Action:

SourceCodeDescription
ATC G02CC02 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE02 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA12 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
FDA Chemical/Ingredient N0000175721 Nonsteroidal Anti-inflammatory Compounds
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Toothache indication 27355003
Tendinitis indication 34840004 DOID:971
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Nasal discharge indication 64531003
Muscle pain indication 68962001
Rheumatoid arthritis indication 69896004 DOID:7148
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hemiplegic migraine contraindication 59292006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Vascular insufficiency of intestine contraindication 82196007
Atrophic gastritis contraindication 84568007 DOID:8929
Epilepsy contraindication 84757009 DOID:1826
Prinzmetal angina contraindication 87343002
Kidney disease contraindication 90708001 DOID:557
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Serotonin syndrome contraindication 371089000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
500MG TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9220698 March 10, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL July 6, 2020 NEW PATIENT POPULATION
500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL July 6, 2020 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.60 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.16 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.50 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 6.32 CHEMBL
Hormone-sensitive lipase Enzyme IC50 5.92 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Cyclooxygenase Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.74 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 4.96 CHEMBL

External reference:

IDSource
4018847 VUID
N0000147149 NUI
C0027396 UMLSCUI
D00118 KEGG_DRUG
57Y76R9ATQ UNII
2979 INN_ID
11847009 SNOMEDCT_US
4018847 VANDF
2111 MMSL
7258 RXNORM
372588000 SNOMEDCT_US
5155 MMSL
d00019 MMSL
002380 NDDF
26159-34-2 SECONDARY_CAS_RN
156391 PUBCHEM_CID
CHEBI:59527 CHEBI
CHEMBL154 ChEMBL_ID
DB00788 DRUGBANK_ID
CHEMBL1200806 ChEMBL_ID
NPS PDB_CHEM_ID
D009288 MESH_DESCRIPTOR_UI
5230 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1005 TABLET, DELAYED RELEASE 375 mg ORAL ANDA 18 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1006 TABLET, DELAYED RELEASE 500 mg ORAL ANDA 18 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-0901 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1773 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
sinus and cold d HUMAN OTC DRUG LABEL 2 0113-2417 TABLET, FILM COATED 220 mg ORAL ANDA 8 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-4368 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7033 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 220 mg ORAL ANDA 10 sections
Basic Care Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-7368 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7901 TABLET, FILM COATED 200 mg ORAL ANDA 8 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 10 sections
Menstridol HUMAN OTC DRUG LABEL 1 0280-0270 TABLET 220 mg ORAL NDA 10 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 9 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 10 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6050 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6060 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6070 TABLET, COATED 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6080 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections
Aleve-D Sinus and Cold HUMAN OTC DRUG LABEL 2 0280-6090 TABLET 220 mg ORAL ANDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6091 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections
Aleve Back and Muscle Pain HUMAN OTC DRUG LABEL 1 0280-6092 TABLET 220 mg ORAL NDA 17 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0102 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
pain relief HUMAN OTC DRUG LABEL 1 0363-0140 TABLET, FILM COATED 220 mg ORAL ANDA 9 sections
All Day Pain Relief HUMAN OTC DRUG LABEL 1 0363-0168 TABLET 220 mg ORAL ANDA 9 sections
All Day Pain Relief HUMAN OTC DRUG LABEL 1 0363-0169 TABLET 220 mg ORAL ANDA 9 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0174 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 9 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0177 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 10 sections