mannitol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	935	69-65-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: d-mannitol mannitol mannitol,d- bronchitol	A diuretic and renal diagnostic aid related to sorbitol. It has little significant energy value as it is largely eliminated from the body before any metabolism can take place. It can be used to treat oliguria associated with kidney failure or other manifestations of inadequate renal function and has been used for determination of glomerular filtration rate. Mannitol is also commonly used as a research tool in cell biological studies, usually to control osmolarity. Molecular weight: 182.17 Formula: C6H14O6 CLOGP: -2.05 LIPINSKI: 1 HAC: 6 HDO: 6 TPSA: 121.38 ALOGS: 0.10 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

d-mannitol
mannitol
mannitol,d-
bronchitol

A diuretic and renal diagnostic aid related to sorbitol. It has little significant energy value as it is largely eliminated from the body before any metabolism can take place. It can be used to treat oliguria associated with kidney failure or other manifestations of inadequate renal function and has been used for determination of glomerular filtration rate. Mannitol is also commonly used as a research tool in cell biological studies, usually to control osmolarity.

Molecular weight: 182.17
Formula: C6H14O6
CLOGP: -2.05
LIPINSKI: 1
HAC: 6
HDO: 6
TPSA: 121.38
ALOGS: 0.10
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.80	g	Inhal.powder

ADMET properties:

Property	Value	Reference
BA (Bioavailability)	7 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.24 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4.70 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	213 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
June 8, 1964	FDA	BAXTER HLTHCARE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Renal injury	209.03	22.50	62	5305	9377	63474278
Fear	189.38	22.50	65	5302	15701	63467954
Renal impairment	178.24	22.50	104	5263	88251	63395404
Anhedonia	126.91	22.50	44	5323	10930	63472725
Renal failure	121.01	22.50	91	5276	117561	63366094
Emotional distress	115.76	22.50	56	5311	32493	63451162
Multiple organ dysfunction syndrome	114.81	22.50	67	5300	56685	63426970
Unevaluable event	110.15	22.50	63	5304	51323	63432332
Injury	101.50	22.50	68	5299	73179	63410476
Anxiety	63.93	22.50	85	5282	217456	63266199
Stress	53.98	22.50	45	5322	67122	63416533
Brain oedema	52.17	22.50	25	5342	14170	63469485
Circulatory collapse	39.35	22.50	24	5343	21914	63461741
Cerebral haemorrhage	38.87	22.50	27	5340	30702	63452953
Chills	35.86	22.50	46	5321	113332	63370323
Coma	33.82	22.50	34	5333	64330	63419325
Maculopathy	33.78	22.50	11	5356	2251	63481404
Propofol infusion syndrome	33.26	22.50	9	5358	974	63482681
Chest discomfort	32.26	22.50	43	5324	109926	63373729
Rash erythematous	31.10	22.50	27	5340	42483	63441172
Haemodynamic instability	30.20	22.50	15	5352	9175	63474480
Cardio-respiratory arrest	28.47	22.50	30	5337	59929	63423726
Plasma cell myeloma refractory	25.75	22.50	6	5361	353	63483302
Hyperkalaemia	25.52	22.50	27	5340	54176	63429479
Brain herniation	25.03	22.50	10	5357	3667	63479988
Disorientation	24.78	22.50	23	5344	39429	63444226
Arthralgia	24.21	22.50	9	5358	569701	62913954
Cerebral toxoplasmosis	24.16	22.50	7	5360	971	63482684
Clostridial sepsis	23.53	22.50	6	5361	515	63483140
Cerebral venous sinus thrombosis	23.14	22.50	8	5359	1964	63481691

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Fear	308.31	20.81	112	8921	10364	34937534
Stress	292.77	20.81	147	8886	30200	34917698
Injury	281.49	20.81	127	8906	20560	34927338
Renal injury	272.01	20.81	104	8929	11091	34936807
Anhedonia	252.98	20.81	89	8944	7496	34940402
Emotional distress	239.08	20.81	103	8930	14923	34932975
Unevaluable event	202.60	20.81	118	8915	32472	34915426
Renal impairment	191.35	20.81	173	8860	94340	34853558
Multiple organ dysfunction syndrome	176.63	20.81	151	8882	76415	34871483
Blood phosphorus increased	149.82	20.81	61	8972	7660	34940238
Appendicolith	146.79	20.81	62	8971	8539	34939359
Renal failure	133.22	20.81	166	8867	130391	34817507
Appendicitis	114.70	20.81	62	8971	14745	34933153
Anxiety	108.71	20.81	131	8902	99297	34848601
Ventricular fibrillation	106.47	20.81	69	8964	22885	34925013
Cardiogenic shock	94.88	20.81	68	8965	26550	34921348
Dry mouth	74.53	20.81	62	8971	30103	34917795
Hyponatraemia	68.41	20.81	95	8938	82596	34865302
Blood uric acid increased	68.17	20.81	38	8995	9586	34938312
Brain oedema	67.65	20.81	43	8990	13778	34934120
Myasthenia gravis	64.96	20.81	33	9000	6907	34940991
Ascites	61.97	20.81	68	8965	46503	34901395
Abdominal distension	58.85	20.81	74	8959	58418	34889480
Pain	55.62	20.81	146	8887	204529	34743369
Incision site pain	55.30	20.81	20	9013	1818	34946080
Red blood cells urine positive	48.20	20.81	18	9015	1791	34946107
Brain herniation	43.26	20.81	21	9012	3987	34943911
Lymphocyte count decreased	42.84	20.81	40	8993	22582	34925316
Blood cholesterol increased	42.16	20.81	38	8995	20505	34927393
Fear of death	36.15	20.81	11	9022	583	34947315
Condition aggravated	35.81	20.81	120	8913	192076	34755822
Constipation	35.38	20.81	96	8937	136886	34811012
Protein urine present	35.27	20.81	20	9013	5208	34942690
Blood urea increased	34.70	20.81	41	8992	30323	34917575
Hypophosphataemia	32.17	20.81	25	9008	11001	34936897
Incorrect route of product administration	31.53	20.81	28	9005	14817	34933081
Optic atrophy	31.49	20.81	11	9022	903	34946995
Sepsis	31.00	20.81	104	8929	166457	34781441
Hyperphosphataemia	30	20.81	17	9016	4420	34943478
Fall	29.50	20.81	8	9025	202877	34745021
Somnolence	27.80	20.81	77	8956	111039	34836859
Analgesic therapy	26.84	20.81	10	9023	988	34946910
General physical health deterioration	26.47	20.81	83	8950	128186	34819712
Abdominal pain	26.00	20.81	97	8936	163521	34784377
Drug therapy	25.54	20.81	10	9023	1131	34946767
Iron deficiency	24.49	20.81	16	9017	5365	34942533
Toxic neuropathy	24.26	20.81	8	9025	551	34947347
Tumour perforation	23.96	20.81	7	9026	322	34947576
Procedural pain	23.62	20.81	15	9018	4791	34943107
Propofol infusion syndrome	23.52	20.81	9	9024	957	34946941
Sleep disorder therapy	23.02	20.81	9	9024	1014	34946884
Optic nerve disorder	22.82	20.81	8	9025	664	34947234
Paresis	22.23	20.81	11	9022	2175	34945723
Blood creatinine increased	21.97	20.81	64	8969	94912	34852986
Complications of transplanted kidney	21.70	20.81	14	9019	4595	34943303
Tick-borne viral encephalitis	21.56	20.81	4	9029	22	34947876
Toxic optic neuropathy	20.99	20.81	8	9025	842	34947056
Product dose omission issue	20.98	20.81	3	9030	119708	34828190

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Renal injury	443.08	18.58	149	13379	16778	79714082
Fear	438.52	18.58	158	13370	21828	79709032
Renal impairment	359.91	18.58	260	13268	157523	79573337
Anhedonia	342.41	18.58	119	13409	14779	79716081
Unevaluable event	306.13	18.58	161	13367	55424	79675436
Emotional distress	303.51	18.58	144	13384	39825	79691035
Stress	300.71	18.58	180	13348	79432	79651428
Injury	297.34	18.58	177	13351	77319	79653541
Multiple organ dysfunction syndrome	269.02	18.58	196	13332	120050	79610810
Renal failure	248.45	18.58	232	13296	200736	79530124
Appendicolith	172.41	18.58	62	13466	8489	79722371
Blood phosphorus increased	157.33	18.58	61	13467	10286	79720574
Anxiety	140.55	18.58	191	13337	248321	79482539
Appendicitis	122.26	18.58	63	13465	20731	79710129
Ventricular fibrillation	117.28	18.58	71	13457	31855	79699005
Brain oedema	105.40	18.58	61	13467	25202	79705658
Cardiogenic shock	101.95	18.58	72	13456	41842	79689018
Hyponatraemia	78.94	18.58	122	13406	177726	79553134
Incision site pain	78.29	18.58	26	13502	2804	79728056
Blood uric acid increased	68.64	18.58	37	13491	13323	79717537
Brain herniation	66.26	18.58	30	13498	7433	79723427
Myasthenia gravis	65.45	18.58	33	13495	10366	79720494
Ascites	65.20	18.58	72	13456	75490	79655370
Lymphocyte count decreased	58.99	18.58	55	13473	47234	79683626
Maculopathy	58.88	18.58	21	13507	2804	79728056
Red blood cells urine positive	57.26	18.58	24	13504	4939	79725921
Arthralgia	52.41	18.58	16	13512	571787	79159073
Abdominal distension	51.53	18.58	81	13447	119569	79611291
Blood urea increased	50.08	18.58	51	13477	48739	79682121
Propofol infusion syndrome	50.03	18.58	17	13511	1966	79728894
Blood creatinine increased	49.65	18.58	92	13436	154965	79575895
Protein urine present	49.16	18.58	27	13501	10085	79720775
Dry mouth	47.12	18.58	66	13462	87953	79642907
Fear of death	46.26	18.58	15	13513	1501	79729359
Fatigue	46.24	18.58	54	13474	929673	78801187
Fall	44.03	18.58	14	13514	487615	79243245
Sepsis	42.72	18.58	121	13407	269307	79461553
Cerebral haemorrhage	39.78	18.58	49	13479	57624	79673236
Neutrophil count increased	38.22	18.58	35	13493	29361	79701499
Hyperphosphataemia	36.55	18.58	19	13509	6357	79724503
Peripheral swelling	34.63	18.58	3	13525	269614	79461246
Chest discomfort	33.51	18.58	73	13455	137971	79592889
Hypophosphataemia	32.52	18.58	27	13501	19886	79710974
Tick-borne viral encephalitis	31.27	18.58	7	13521	168	79730692
Pain	31.20	18.58	215	13313	703587	79027273
Analgesic therapy	30.85	18.58	10	13518	999	79729861
Coma	30.06	18.58	58	13470	100591	79630269
Intracranial pressure increased	29.24	18.58	18	13510	8304	79722556
Drug therapy	29.14	18.58	10	13518	1191	79729669
Product dose omission issue	28.64	18.58	4	13524	247533	79483327
Complications of transplanted kidney	28.22	18.58	16	13512	6350	79724510
Optic atrophy	27.97	18.58	11	13517	1922	79728938
Brain death	27.16	18.58	15	13513	5662	79725198
Sleep disorder therapy	26.71	18.58	9	13519	1015	79729845
Incorrect route of product administration	26.25	18.58	31	13497	34898	79695962
Constipation	26.08	18.58	106	13422	282944	79447916
Hepatic function abnormal	25.44	18.58	45	13483	73062	79657798
Rheumatoid arthritis	25.00	18.58	3	13525	208467	79522393
Abdominal discomfort	24.83	18.58	6	13522	250721	79480139
Weight decreased	24.47	18.58	15	13513	355183	79375677
Psychological trauma	23.92	18.58	9	13519	1397	79729463
Anaphylactic shock	23.88	18.58	30	13498	35966	79694894
Nasopharyngitis	23.40	18.58	7	13521	253874	79476986
Rash erythematous	23.33	18.58	38	13490	57731	79673129
Weight increased	23.22	18.58	9	13519	277377	79453483
Toxic neuropathy	23.16	18.58	8	13520	972	79729888
Hyperkalaemia	22.80	18.58	56	13472	114342	79616518
Chemical burn	22.80	18.58	7	13521	586	79730274
Somnolence	22.41	18.58	90	13438	238891	79491969
Alopecia	22.02	18.58	6	13522	231349	79499511
Acute kidney injury	21.98	18.58	157	13371	519247	79211613
Toxic optic neuropathy	21.89	18.58	8	13520	1145	79729715
Optic nerve disorder	21.09	18.58	8	13520	1269	79729591
Iron deficiency	20.71	18.58	16	13512	10638	79720222
Pain in extremity	20.49	18.58	19	13509	364519	79366341
Diarrhoea	20.23	18.58	79	13449	880410	78850450
Condition aggravated	19.78	18.58	149	13379	500975	79229885
Paresis	19.67	18.58	11	13517	4250	79726610
Hypokalaemia	19.29	18.58	61	13467	143979	79586881
Chills	18.90	18.58	65	13463	160169	79570691
Sinusitis	18.73	18.58	5	13523	195496	79535364
White blood cell count increased	18.70	18.58	40	13488	74593	79656267
Hydrocephalus	18.70	18.58	14	13514	8886	79721974

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A06AD16	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives
ATC	B05BC01	BLOOD AND BLOOD FORMING ORGANS BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS I.V. SOLUTIONS Solutions producing osmotic diuresis
ATC	B05CX04	BLOOD AND BLOOD FORMING ORGANS BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS IRRIGATING SOLUTIONS Other irrigating solutions
ATC	R05CB16	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS Mucolytics
ATC	V04CX04	VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents
FDA MoA	N0000010288	Osmotic Activity
FDA PE	N0000175359	Increased Diuresis
MeSH PA	D004232	Diuretics
MeSH PA	D004234	Diuretics, Osmotic
MeSH PA	D005421	Flavoring Agents
MeSH PA	D005503	Food Additives
MeSH PA	D045283	Natriuretic Agents
MeSH PA	D013549	Sweetening Agents
FDA EPC	N0000175810	Osmotic Diuretic
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:39456	antiglaucoma agent
CHEBI has role	CHEBI:50505	sweeteners
CHEBI has role	CHEBI:50904	alergeno
CHEBI has role	CHEBI:59174	haptens
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:77965	food anti-caking agent
CHEBI has role	CHEBI:77966	food stabilisers
CHEBI has role	CHEBI:77969	food humectants
CHEBI has role	CHEBI:77970	thickening agents
CHEBI has role	CHEBI:78004	food bulking agents
CHEBI has role	CHEBI:75772	S. cerevisiae metabolites
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

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

Disease	Relation	SNOMED_ID	DOID
Cerebral edema	indication	2032001
Ocular hypertension	indication	4210003	DOID:9282
Benign intracranial hypertension	indication	68267002	DOID:11459
Cystic fibrosis	indication	190905008	DOID:1485
Edema	indication	267038008
Hemolysis Prevention	indication
Intracranial hemorrhage	contraindication	1386000
Anuria	contraindication	2472002	DOID:2983
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Hyperammonemia	contraindication	9360008
Hepatic encephalopathy	contraindication	13920009	DOID:13413
Hyperkalemia	contraindication	14140009
Hypovolemia	contraindication	28560003
Depressive disorder	contraindication	35489007
Hypernatremia	contraindication	39355002
Chronic heart failure	contraindication	48447003
Hepatic failure	contraindication	59927004
Poisoning by phenobarbital	contraindication	64921004
Substance abuse	contraindication	66214007
Pulmonary congestion	contraindication	67599009
Hepatic coma	contraindication	72836002	DOID:12550
Sleep apnea	contraindication	73430006	DOID:0050847
Oliguria	contraindication	83128009
Hyponatremia	contraindication	89627008
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Fragile capillaries	contraindication	248726001
Dyspnea	contraindication	267036007
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Breastfeeding (mother)	contraindication	413712001
Porphyria	contraindication	418470004
Severe dehydration	contraindication	450316000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.21	acidic
pKa2	13.75	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
40MG	BRONCHITOL	CHIESI	N202049	Oct. 30, 2020	RX	POWDER	INHALATION	Oct. 30, 2023	NEW PRODUCT
40MG	BRONCHITOL	CHIESI	N202049	Oct. 30, 2020	RX	POWDER	INHALATION	Oct. 30, 2027	ADD-ON MAINTENANCE THERAPY TO IMPROVE PULMONARY FUNCTION IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WITH CYSTIC FIBROSIS AND WHO HAVE PASSED THE BRONCHITOL TOLERANCE TEST

Bioactivity Summary:

None

External reference:

ID	Source
4017741	VUID
N0000146108	NUI
D00062	KEGG_DRUG
2475836	RXNORM
4017741	VANDF
C0024730	UMLSCUI
CHEBI:29864	CHEBI
MTL	PDB_CHEM_ID
CHEMBL689	ChEMBL_ID
D008353	MESH_DESCRIPTOR_UI
DB00742	DRUGBANK_ID
3OWL53L36A	UNII
6251	PUBCHEM_CID
189996	MMSL
5022	MMSL
7928	MMSL
d00282	MMSL
002272	NDDF
004521	NDDF
30761007	SNOMEDCT_US
387168006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0264-7578	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	22 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0264-7578	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	22 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0264-7578	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	22 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0351	INJECTION, SOLUTION	5 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0351	INJECTION, SOLUTION	5 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0353	INJECTION, SOLUTION	10 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0353	INJECTION, SOLUTION	10 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0355	INJECTION, SOLUTION	15 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0355	INJECTION, SOLUTION	15 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0357	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	23 sections
Osmitrol	HUMAN PRESCRIPTION DRUG LABEL	1	0338-0357	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	23 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9905	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	17 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9905	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	17 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0409-4031	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	24 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0990-7715	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	24 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	0990-7715	INJECTION, SOLUTION	20 g	INTRAVENOUS	NDA	24 sections
Sorbitol-Mannitol	HUMAN PRESCRIPTION DRUG LABEL	2	0990-7981	IRRIGANT	0.54 g	URETHRAL	NDA	12 sections
Sorbitol-Mannitol	HUMAN PRESCRIPTION DRUG LABEL	2	0990-7981	IRRIGANT	0.54 g	URETHRAL	NDA	12 sections
Bronchitol	HUMAN PRESCRIPTION DRUG LABEL	1	10122-212	CAPSULE	40 mg	RESPIRATORY (INHALATION)	NDA	28 sections
MANNITOL	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1468	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	17 sections
MANNITOL	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1468	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	17 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	52584-031	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	16 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	52584-031	INJECTION, SOLUTION	12.50 g	INTRAVENOUS	NDA	16 sections
GD11 Rx SCM C5	HUMAN OTC DRUG LABEL	1	62171-100	LIQUID	0.10 g	TOPICAL	unapproved drug other	8 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	63323-024	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	11 sections
Mannitol	HUMAN PRESCRIPTION DRUG LABEL	1	63323-024	INJECTION, SOLUTION	250 mg	INTRAVENOUS	ANDA	11 sections
QR PAIN	HUMAN OTC DRUG LABEL	2	73180-005	CREAM	30 g	TOPICAL	OTC monograph not final	12 sections
QR PAIN	HUMAN OTC DRUG LABEL	2	73180-005	CREAM	30 g	TOPICAL	OTC monograph not final	12 sections
QR PAIN	HUMAN OTC DRUG LABEL	2	73180-075	CREAM	30 g	TOPICAL	OTC monograph not final	12 sections
QR PAIN	HUMAN OTC DRUG LABEL	2	73180-075	CREAM	30 g	TOPICAL	OTC monograph not final	12 sections