sodium fluoride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
4243 7681-49-4

Description:

MoleculeDescription

Synonyms:

  • sodium fluoride
  • sodium monofluoride
A source of inorganic fluoride which is used topically to prevent dental caries.
  • Molecular weight: 41.99
  • Formula: FNa
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1.10 mg O
88 mg O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
July 11, 1997 FDA COLGATE PALMOLIVE

FDA Adverse Event Reporting System (Female)

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
Walking aid user 121.72 17.24 66 10392 35440 90582549
Prescribed underdose 115.82 17.24 84 10374 74935 90543054
Seronegative arthritis 98.10 17.24 46 10412 18188 90599801
Wound infection 91.99 17.24 85 10373 106317 90511672
Upper respiratory tract infection 80.35 17.24 86 10372 128232 90489757
Spinal fusion surgery 78.70 17.24 35 10423 12248 90605741
Visual impairment 71.29 17.24 82 10376 132283 90485706
Joint dislocation 71.23 17.24 51 10407 44531 90573458
Spondylitis 61.87 17.24 31 10427 14147 90603842
Lupus vulgaris 61.76 17.24 47 10411 45012 90572977
Drug ineffective 59.66 17.24 44 10414 1384254 89233735
Retinitis 59.16 17.24 43 10415 38415 90579574
Osteoporosis 57.43 17.24 63 10395 96468 90521521
Type 2 diabetes mellitus 56.06 17.24 91 10367 203153 90414836
Laryngitis 54.74 17.24 46 10412 50707 90567282
Joint stiffness 53.63 17.24 55 10403 77987 90540002
Anti-cyclic citrullinated peptide antibody 50.17 17.24 34 10424 27187 90590802
Lupus-like syndrome 50.08 17.24 43 10415 48803 90569186
Foot deformity 48.34 17.24 46 10412 59605 90558384
Hepatic cirrhosis 47.91 17.24 47 10411 63206 90554783
Adjustment disorder with depressed mood 46.43 17.24 44 10414 56709 90561280
Dislocation of vertebra 43.16 17.24 42 10416 55926 90562063
Urticaria 41.33 17.24 103 10355 312631 90305358
Exostosis 41.21 17.24 40 10418 53094 90564895
Wheezing 40.93 17.24 87 10371 237993 90379996
Liver function test increased 38.17 17.24 48 10410 84807 90533182
Disability 38.01 17.24 34 10424 40711 90577278
Sciatica 35.86 17.24 51 10407 101331 90516658
Prescribed overdose 35.85 17.24 50 10408 97575 90520414
Bone erosion 35.75 17.24 37 10421 52984 90565005
Ear infection 35.48 17.24 42 10416 69733 90548256
Osteoarthritis 35.35 17.24 73 10385 195657 90422332
Deep vein thrombosis postoperative 34.98 17.24 42 10416 70767 90547222
Grip strength decreased 34.87 17.24 48 10410 92528 90525461
Hip arthroplasty 34.10 17.24 43 10415 76165 90541824
Red blood cell sedimentation rate increased 32.89 17.24 44 10414 82551 90535438
Lower limb fracture 31.90 17.24 44 10414 84969 90533020
Road traffic accident 30.74 17.24 49 10409 107577 90510412
Oedema 29.68 17.24 69 10389 200226 90417763
Autoimmune disorder 29.21 17.24 40 10418 76704 90541285
Delirium 29.10 17.24 47 10411 104312 90513677
Hypercholesterolaemia 28.90 17.24 46 10412 100846 90517143
Pulmonary fibrosis 28.07 17.24 47 10411 107456 90510533
Weight increased 27.47 17.24 108 10350 417819 90200170
Joint range of motion decreased 27.36 17.24 53 10405 135590 90482399
Off label use 27.19 17.24 54 10404 1102198 89515791
Wound 25.60 17.24 85 10373 302895 90315094
Amnesia 25.14 17.24 45 10413 108460 90509529
Swollen joint count increased 24.34 17.24 45 10413 111161 90506828
Vertebral lateral recess stenosis 24.01 17.24 6 10452 346 90617643
Osteoarthropathy 23.75 17.24 6 10452 362 90617627
Ligamentum flavum hypertrophy 23.61 17.24 6 10452 371 90617618
Gait inability 23.40 17.24 52 10406 146404 90471585
Fibromyalgia 23.18 17.24 64 10394 206205 90411784
Psoriasis 23.09 17.24 52 10406 147702 90470287
Weight decreased 22.43 17.24 95 10363 379815 90238174
Breast cancer stage III 22.15 17.24 37 10421 84410 90533579
Nasopharyngitis 21.91 17.24 99 10359 407005 90210984
Tachycardia 20.86 17.24 52 10406 157621 90460368
Toe operation 20.79 17.24 7 10451 1161 90616828
Rheumatic fever 19.73 17.24 50 10408 153071 90464918
Sleep disorder due to a general medical condition 19.62 17.24 25 10433 44713 90573276
Trifascicular block 18.75 17.24 4 10454 114 90617875
Knee arthroplasty 18.63 17.24 34 10424 83148 90534841
Drug-induced liver injury 17.85 17.24 35 10423 90283 90527706
Hypoaesthesia eye 17.74 17.24 5 10453 459 90617530
Liver injury 17.29 17.24 51 10407 170516 90447473

FDA Adverse Event Reporting System (Male)

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
Respiratory tract infection bacterial 96.62 23.77 22 2236 1887 42617190
Respiratory tract infection viral 88.80 23.77 23 2235 3383 42615694
Respiratory tract infection 54.55 23.77 27 2231 26295 42592782
Fibrin D dimer increased 54.13 23.77 17 2241 4968 42614109
Cytokine release syndrome 51.39 23.77 31 2227 44496 42574581
Cystitis viral 40.33 23.77 10 2248 1232 42617845
Human polyomavirus infection 39.85 23.77 10 2248 1293 42617784
Lymphoma 39.82 23.77 18 2240 14303 42604774
Eye infection 35.66 23.77 12 2246 4349 42614728
Somnambulism 34.39 23.77 11 2247 3404 42615673
Cytomegalovirus infection reactivation 24.73 23.77 12 2246 11166 42607911
C-reactive protein increased 24.65 23.77 23 2235 63537 42555540
Sinusitis 24.12 23.77 20 2238 47272 42571805
Platelet count decreased 24.09 23.77 33 2225 138548 42480529

FDA Adverse Event Reporting System (Geriatric)

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
Respiratory tract infection bacterial 87.40 15.07 22 7012 2394 110579871
Respiratory tract infection viral 72.16 15.07 23 7011 5855 110576410
Cytokine release syndrome 43.63 15.07 36 6998 70270 110511995
Fibrin D dimer increased 39.77 15.07 17 7017 9828 110572437
Cystitis viral 36.80 15.07 10 7024 1463 110580802
Human polyomavirus infection 34.81 15.07 10 7024 1792 110580473
Vertebral lateral recess stenosis 27.57 15.07 6 7028 346 110581919
Ligamentum flavum hypertrophy 27.19 15.07 6 7028 369 110581896
Osteoarthropathy 27.13 15.07 6 7028 373 110581892
Respiratory tract infection 25.64 15.07 27 7007 71590 110510675
Spinal fusion surgery 24.90 15.07 12 7022 9144 110573121
Seronegative arthritis 23.49 15.07 13 7021 13164 110569101
Toe operation 21.27 15.07 6 7028 1008 110581257
Myotonic dystrophy 19.04 15.07 4 7030 195 110582070
Trifascicular block 18.69 15.07 4 7030 213 110582052
Adjustment disorder with depressed mood 18.36 15.07 18 7016 43865 110538400
Acute graft versus host disease in skin 17.53 15.07 10 7024 10730 110571535
Drug ineffective 17.48 15.07 45 6989 1520495 109061770
Cytomegalovirus infection reactivation 17.15 15.07 12 7022 18321 110563944
Myelodysplastic syndrome 16.86 15.07 16 7018 37468 110544797
Stomatitis 16.53 15.07 46 6988 270196 110312069
Ototoxicity 16.24 15.07 7 7027 4124 110578141
Hypoaesthesia eye 16.21 15.07 4 7030 401 110581864
Lymphoma 16.12 15.07 12 7022 20159 110562106
Abscess neck 15.35 15.07 5 7029 1363 110580902
C-reactive protein increased 15.25 15.07 39 6995 217880 110364385

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AA01 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Caries prophylactic agents
ATC A01AA51 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Caries prophylactic agents
ATC A12CD01 ALIMENTARY TRACT AND METABOLISM
MINERAL SUPPLEMENTS
OTHER MINERAL SUPPLEMENTS
Fluoride
MeSH PA D002327 Cariostatic Agents
MeSH PA D020011 Protective Agents
CHEBI has role CHEBI:25435 mutagen
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50646 bone density conservation agent

Related Drugs by ATC class:

A01AA Caries prophylactic agents 3 drugs
olaflursodium monofluorophosphatestannous fluoride
A12CD Fluoride 1 drug
sodium monofluorophosphate

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Vitamin deficiency indication 85670002
Prevention of dental caries indication 426482000
Gingivitis off-label use 66383009 DOID:3087
Dental Plaque Prevention off-label use
Constipation contraindication 14760008 DOID:2089
Dental fluorosis contraindication 30265004
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Osteolysis contraindication 203522001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
8ZYQ1474W7 UNII
4020179 VUID
N0000148121 NUI
D00943 KEGG_DRUG
4017647 VANDF
4017665 VANDF
4020179 VANDF
C0037508 UMLSCUI
CHEBI:28741 CHEBI
CHEMBL1528 ChEMBL_ID
5235 PUBCHEM_CID
DB09325 DRUGBANK_ID
D012969 MESH_DESCRIPTOR_UI
9873 RXNORM
1752 MMSL
4742 MMSL
5482 MMSL
001103 NDDF
329199009 SNOMEDCT_US
6910009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Oral-B Minute-Foam Orang-A-Tangy HUMAN PRESCRIPTION DRUG LABEL 2 0041-0342 AEROSOL 10 mg DENTAL unapproved drug other 18 sections
Oral-B Anticavity HUMAN OTC DRUG LABEL 1 0041-1421 LIQUID 500 ug DENTAL OTC monograph not final 13 sections
PreviDent5000 Dry Mouth HUMAN PRESCRIPTION DRUG LABEL 1 0126-0016 GEL, DENTIFRICE 6.10 mg DENTAL UNAPPROVED DRUG OTHER 20 sections
PreviDent 5000 Enamel Protect HUMAN PRESCRIPTION DRUG LABEL 2 0126-0022 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride HUMAN OTC DRUG LABEL 1 0126-0032 RINSE 2 mg DENTAL OTC MONOGRAPH DRUG 11 sections
PreviDent Alcohol Free HUMAN PRESCRIPTION DRUG LABEL 1 0126-0033 MOUTHWASH 0.90 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride HUMAN OTC DRUG LABEL 1 0126-0034 RINSE 2 mg DENTAL OTC MONOGRAPH DRUG 11 sections
PreviDent 5000 Sensitive HUMAN PRESCRIPTION DRUG LABEL 2 0126-0070 GEL, DENTIFRICE 5.80 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0072 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0072 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Booster Plus Spearmint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0074 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Fresh Mint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0088 GEL, DENTIFRICE 5 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent5000 Plus Fruitastic HUMAN PRESCRIPTION DRUG LABEL 1 0126-0286 PASTE, DENTIFRICE 11 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent5000 Plus Spearmint HUMAN PRESCRIPTION DRUG LABEL 1 0126-0287 PASTE, DENTIFRICE 11 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent Very Berry HUMAN PRESCRIPTION DRUG LABEL 1 0126-0288 GEL, DENTIFRICE 5 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent OrthoDefense HUMAN PRESCRIPTION DRUG LABEL 1 0126-0289 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 21 sections
PreviDent 5000 Kids HUMAN PRESCRIPTION DRUG LABEL 1 0126-0311 PASTE, DENTIFRICE 6 mg DENTAL UNAPPROVED DRUG OTHER 22 sections
AQUAFRESH EXTREME CLEAN WHITENING ACTION HUMAN OTC DRUG LABEL 1 0135-0234 PASTE 1.13 mg DENTAL OTC Monograph Drug 11 sections
AQUAFRESH EXTREME CLEAN DEEP ACTION HUMAN OTC DRUG LABEL 1 0135-0432 PASTE 1.13 mg DENTAL OTC Monograph Drug 11 sections
SENSODYNE PRONAMELIntensive Enamel Repair Clean Mint HUMAN OTC DRUG LABEL 1 0135-0449 LIQUID 0.50 mg ORAL OTC Monograph Drug 10 sections
SENSODYNE PRONAMELmineral BOOST refreshing peppermint HUMAN OTC DRUG LABEL 2 0135-0450 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections
SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh HUMAN OTC DRUG LABEL 1 0135-0451 LIQUID 0.50 mg ORAL OTC Monograph Drug 10 sections
SENSODYNE PRONAMEL Daily Protection HUMAN OTC DRUG LABEL 2 0135-0460 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections
SENSODYNE Advanced Whitening HUMAN OTC DRUG LABEL 2 0135-0479 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections
SENSODYNE PRONAMELmineral BOOST whitening action HUMAN OTC DRUG LABEL 2 0135-0480 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening HUMAN OTC DRUG LABEL 2 0135-0481 PASTE 1.15 mg ORAL OTC Monograph Drug 12 sections
SENSODYNE PRONAMEL Gentle Whitening HUMAN OTC DRUG LABEL 2 0135-0484 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections
SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh HUMAN OTC DRUG LABEL 2 0135-0486 PASTE 1.15 mg ORAL OTC Monograph Drug 12 sections
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint HUMAN OTC DRUG LABEL 2 0135-0492 PASTE 1.15 mg ORAL OTC Monograph Drug 12 sections
SENSODYNE PRONAMEL Fresh Breath HUMAN OTC DRUG LABEL 2 0135-0520 PASTE 1.15 mg ORAL OTC Monograph Drug 11 sections