glycerol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1316	56-81-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: glycerol glycerin glycerine propane-1,2,3-triol 1,2,3-triglycerol glycyl alcohol	A trihydroxy sugar alcohol that is an intermediate in carbohydrate and lipid metabolism. It is used as a solvent, emollient, pharmaceutical agent, or sweetening agent. Molecular weight: 92.09 Formula: C3H8O3 CLOGP: -1.54 LIPINSKI: 0 HAC: 3 HDO: 3 TPSA: 60.69 ALOGS: 1.10 ROTB: 2

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 6, 1982	FDA	B BRAUN

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
Completed suicide	3739.37	12.87	1717	23022	144203	46517120
Toxicity to various agents	2279.82	12.87	1400	23339	210366	46450957
Drug abuse	844.83	12.87	484	24255	62924	46598399
Intentional overdose	820.76	12.87	479	24260	64465	46596858
Cardio-respiratory arrest	752.18	12.87	440	24299	59429	46601894
Overdose	550.38	12.87	445	24294	101534	46559789
Suicide attempt	513.87	12.87	335	24404	54701	46606622
Alcohol interaction	371.23	12.87	108	24631	2337	46658986
Suspected suicide	229.06	12.87	88	24651	4573	46656750
Alcohol poisoning	215.82	12.87	70	24669	2198	46659125
Intentional product misuse	206.96	12.87	183	24556	46945	46614378
Alcohol use	187.05	12.87	64	24675	2378	46658945
Respiratory arrest	180.63	12.87	147	24592	33669	46627654
Eye irritation	159.32	12.87	103	24636	16511	46644812
Alcohol abuse	147.36	12.87	52	24687	2120	46659203
Cardiac arrest	137.08	12.87	202	24537	90197	46571126
Coma	127.72	12.87	156	24583	58193	46603130
Somnolence	124.11	12.87	263	24476	156258	46505065
Death	100.67	12.87	397	24342	335151	46326172
Drug ineffective	94.10	12.87	134	24605	677704	45983619
Rheumatoid arthritis	82.65	12.87	14	24725	240201	46421122
Alcoholism	74.93	12.87	32	24707	2186	46659137
Blood alcohol increased	70.81	12.87	23	24716	725	46660598
Eye pain	68.17	12.87	79	24660	27861	46633462
Arthralgia	64.58	12.87	59	24680	364544	46296779
Poisoning deliberate	63.59	12.87	44	24695	7882	46653441
Loss of consciousness	61.71	12.87	160	24579	108078	46553245
Joint swelling	60.95	12.87	8	24731	166065	46495258
Mydriasis	60.82	12.87	48	24691	10505	46650818
Exposure to toxic agent	58.10	12.87	26	24713	1988	46659335
Agitation	54.48	12.87	102	24637	55313	46606010
Drug hypersensitivity	51.35	12.87	33	24706	243792	46417531
Substance abuse	50.50	12.87	30	24709	4137	46657186
Aggression	50.02	12.87	61	24678	22683	46638640
Intentional self-injury	48.64	12.87	62	24677	24104	46637219
Victim of sexual abuse	48.44	12.87	16	24723	532	46660791
Depressed level of consciousness	47.31	12.87	88	24651	47481	46613842
Foreign body sensation in eyes	47.14	12.87	22	24717	1854	46659469
Pain	46.78	12.87	116	24623	476832	46184491
Fatigue	43.50	12.87	171	24568	608526	46052797
Postmortem blood drug level abnormal	43.27	12.87	13	24726	315	46661008
Ocular hyperaemia	41.95	12.87	52	24687	19658	46641665
Scleral hyperaemia	40.82	12.87	12	24727	269	46661054
Seizure	40.31	12.87	150	24589	122904	46538419
Condition aggravated	37.31	12.87	45	24694	245007	46416316
Drug intolerance	36.67	12.87	16	24723	147033	46514290
Drug withdrawal syndrome	35.53	12.87	57	24682	27327	46633996
Peripheral swelling	35.20	12.87	20	24719	158051	46503272
Myocarditis	33.81	12.87	30	24709	7709	46653614
Drug dependence	33.81	12.87	47	24692	19854	46641469
Hyperpyrexia	33.74	12.87	20	24719	2746	46658577
Instillation site pain	33.67	12.87	14	24725	894	46660429
Treatment failure	32.92	12.87	5	24734	93082	46568241
Suicidal ideation	32.77	12.87	84	24655	56298	46605025
Liver injury	32.12	12.87	41	24698	15960	46645363
Somnambulism	31.39	12.87	24	24715	5013	46656310
Drug use disorder	31.35	12.87	19	24720	2716	46658607
Poisoning	29.91	12.87	37	24702	13957	46647366
Electrocardiogram QRS complex prolonged	29.72	12.87	24	24715	5425	46655898
Sinusitis	29.49	12.87	16	24723	129752	46531571
Pneumonia	29.22	12.87	102	24637	376218	46285105
Dyspnoea	28.94	12.87	158	24581	515390	46145933
Homicide	27.69	12.87	10	24729	436	46660887
Eye discharge	27.51	12.87	22	24717	4906	46656417
Amnesia	27.34	12.87	65	24674	41566	46619757
Tachycardia	26.63	12.87	114	24625	99508	46561815
Chills	26.53	12.87	111	24628	95921	46565402
Weight increased	26.31	12.87	29	24710	164444	46496879
Abdominal discomfort	26.05	12.87	25	24714	151140	46510183
Nasopharyngitis	25.93	12.87	26	24713	153972	46507351
Chemical submission	24.88	12.87	8	24731	244	46661079
Swelling	24.64	12.87	18	24721	124493	46536830
Alopecia	24.51	12.87	30	24709	162384	46498939
Electrocardiogram QT prolonged	24.37	12.87	71	24668	51254	46610069
Macular degeneration	23.95	12.87	24	24715	7181	46654142
Shock	23.72	12.87	42	24697	21803	46639520
Protein C increased	23.36	12.87	7	24732	168	46661155
Anaemia	22.87	12.87	65	24674	255714	46405609
Rash	22.39	12.87	105	24634	356407	46304916
Synovitis	22.25	12.87	3	24736	61072	46600251
Infusion related reaction	22.24	12.87	13	24726	101195	46560128
Diarrhoea	22.19	12.87	190	24549	559412	46101911
Therapeutic product effect incomplete	21.99	12.87	7	24732	78146	46583177
Sedation complication	21.91	12.87	17	24722	3628	46657695
Accidental death	21.68	12.87	13	24726	1822	46659501
Substance dependence	21.60	12.87	7	24732	219	46661104
Erythema of eyelid	21.52	12.87	13	24726	1848	46659475
Sopor	21.37	12.87	38	24701	19790	46641533
Sedation	21.06	12.87	41	24698	22869	46638454
Abnormal behaviour	20.98	12.87	39	24700	21019	46640304
Metabolic acidosis	20.72	12.87	56	24683	38724	46622599
Therapeutic product effect decreased	20.56	12.87	9	24730	82592	46578731
Induced abortion failed	20.38	12.87	7	24732	263	46661060
Asphyxia	20.06	12.87	19	24720	5307	46656016
Arthropathy	19.89	12.87	10	24729	84690	46576633
Congenital umbilical hernia	19.88	12.87	8	24731	470	46660853
Alcoholic	19.56	12.87	5	24734	65	46661258
Injection site pain	19.31	12.87	17	24722	107135	46554188
Weight decreased	19.27	12.87	53	24686	210796	46450527
Superinfection	19.24	12.87	12	24727	1805	46659518
Bronchitis	18.88	12.87	17	24722	105962	46555361
Pain in extremity	18.80	12.87	72	24667	258608	46402715
Infection	18.79	12.87	26	24713	133566	46527757
Incorrect route of product administration	18.44	12.87	32	24707	16351	46644972
Hyperlipasaemia	18.07	12.87	8	24731	596	46660727
Neonatal infection	18.01	12.87	6	24733	205	46661118
Euphoric mood	17.56	12.87	16	24723	4256	46657067
Toxicologic test abnormal	16.95	12.87	8	24731	691	46660632
Drug level increased	16.94	12.87	33	24706	18408	46642915
Sinus tachycardia	16.65	12.87	36	24703	21613	46639710
Product dose omission issue	16.43	12.87	41	24698	168479	46492844
Dry eye	16.41	12.87	44	24695	30278	46631045
Ejection fraction decreased	16.36	12.87	32	24707	17905	46643418
Herpes zoster	15.96	12.87	8	24731	67864	46593459
Areflexia	15.82	12.87	13	24726	3010	46658313
Unresponsive to stimuli	15.74	12.87	45	24694	32129	46629194
Headache	15.71	12.87	170	24569	478182	46183141
Alcohol withdrawal syndrome	15.58	12.87	8	24731	829	46660494
Coma scale abnormal	15.41	12.87	16	24723	4990	46656333
Superficial injury of eye	15.20	12.87	5	24734	164	46661159
Cardiac death	15.15	12.87	7	24732	576	46660747
Osteoarthritis	15.06	12.87	7	24732	62018	46599305
Duodenal stenosis	15.05	12.87	7	24732	585	46660738
Disinhibition	14.95	12.87	8	24731	903	46660420
Musculoskeletal stiffness	14.88	12.87	18	24721	97975	46563348
Asthma	14.78	12.87	16	24723	91526	46569797
Neutropenia	14.62	12.87	34	24705	143170	46518153
Eyelid irritation	14.60	12.87	6	24733	372	46660951
Brain death	14.48	12.87	12	24727	2811	46658512
Slow speech	14.42	12.87	9	24730	1355	46659968
Aspiration	13.98	12.87	21	24718	9510	46651813
Ventricular tachycardia	13.96	12.87	29	24710	16938	46644385
Accidental overdose	13.90	12.87	32	24707	20034	46641289
Hypotension	13.88	12.87	186	24553	232403	46428920
Oral mucosal roughening	13.80	12.87	3	24736	18	46661305
Abdominal pain upper	13.66	12.87	36	24703	145269	46516054
Respiratory depression	13.50	12.87	23	24716	11577	46649746
Pulmonary embolism	13.47	12.87	23	24716	108562	46552761
Birth mark	13.47	12.87	5	24734	236	46661087
Road traffic accident	13.45	12.87	35	24704	23656	46637667
Leukopenia	13.36	12.87	10	24729	68333	46592990
Off label use	13.27	12.87	133	24606	379708	46281615
Dizziness	13.26	12.87	116	24623	340298	46321025
Drug abuser	13.07	12.87	12	24727	3221	46658102
Drug screen positive	13.00	12.87	13	24726	3878	46657445
Lacrimation increased	12.92	12.87	27	24712	15834	46645489

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
Drug abuse	2546.98	14.47	1240	21783	80832	29848623
Completed suicide	2521.72	14.47	1310	21713	98182	29831273
Toxicity to various agents	2360.46	14.47	1534	21489	175649	29753806
Intentional overdose	669.60	14.47	409	22614	41072	29888383
Cardio-respiratory arrest	529.29	14.47	400	22623	56906	29872549
Alcohol abuse	493.57	14.47	177	22846	5176	29924279
Overdose	482.17	14.47	446	22577	83891	29845564
Suicide attempt	443.84	14.47	302	22721	36395	29893060
Alcohol interaction	383.70	14.47	124	22899	2618	29926837
Intentional product misuse	360.12	14.47	260	22763	34407	29895048
Alcohol poisoning	229.33	14.47	92	22931	3672	29925783
Suspected suicide	226.88	14.47	87	22936	3074	29926381
Substance abuse	217.96	14.47	107	22916	6933	29922522
Drug dependence	179.34	14.47	141	22882	21154	29908301
Alcohol use	159.38	14.47	71	22952	3684	29925771
Coma	120.63	14.47	152	22871	40297	29889158
Respiratory arrest	117.32	14.47	128	22895	29130	29900325
Aggression	110.53	14.47	139	22884	36768	29892687
Poisoning deliberate	104.72	14.47	62	22961	5842	29923613
Asphyxia	104.22	14.47	60	22963	5365	29924090
Incorrect route of product administration	99.72	14.47	77	22946	11238	29918217
Respiratory depression	98.60	14.47	77	22946	11426	29918029
Blood alcohol increased	90.35	14.47	32	22991	899	29928556
Intentional product use issue	85.72	14.47	122	22901	36318	29893137
Drug ineffective	84.04	14.47	83	22940	340304	29589151
Cardiac arrest	68.70	14.47	191	22832	92659	29836796
Drug withdrawal syndrome	68.04	14.47	80	22943	19729	29909726
Intentional self-injury	64.58	14.47	65	22958	13467	29915988
Poisoning	60.51	14.47	58	22965	11324	29918131
Alcohol withdrawal syndrome	60.24	14.47	28	22995	1603	29927852
Suicidal ideation	56.03	14.47	100	22923	36014	29893441
Diarrhoea	53.17	14.47	111	22912	333992	29595463
Ocular procedural complication	53.12	14.47	12	23011	57	29929398
Fatigue	48.96	14.47	109	22914	320564	29608891
Temperature intolerance	46.79	14.47	29	22994	2966	29926489
Sopor	45.62	14.47	49	22974	10942	29918513
Accidental death	45.36	14.47	25	22998	2054	29927401
Alcoholism	43.31	14.47	29	22994	3385	29926070
Road traffic accident	42.86	14.47	59	22964	17012	29912443
Dyspnoea	42.59	14.47	124	22899	333171	29596284
Pneumonia	41.55	14.47	126	22897	334180	29595275
Drug screen positive	41.04	14.47	31	22992	4376	29925079
Neutropenia	40.96	14.47	24	22999	128516	29800939
Hyperpyrexia	40.38	14.47	25	22998	2552	29926903
Anaemia	40.31	14.47	61	22962	207931	29721524
Ex-drug abuser	39.65	14.47	12	23011	202	29929253
Alcohol intolerance	38.47	14.47	14	23009	426	29929029
Amnesia	37.27	14.47	67	22956	24254	29905201
Drug abuser	34.57	14.47	28	22995	4373	29925082
Medication error	33.71	14.47	59	22964	20913	29908542
Rash	33.70	14.47	60	22963	191829	29737626
Hepatic fibrosis	32.93	14.47	25	22998	3555	29925900
Miosis	32.86	14.47	35	22988	7741	29921714
Chills	31.97	14.47	125	22898	72213	29857242
Exposure to toxic agent	31.56	14.47	16	23007	1109	29928346
Infection	30.40	14.47	11	23012	78063	29851392
Homicide	29.70	14.47	15	23008	1031	29928424
Depressed level of consciousness	29.57	14.47	80	22943	38142	29891313
Agitation	29.43	14.47	100	22923	53973	29875482
Pain in extremity	29.29	14.47	25	22998	110196	29819259
Arthralgia	29.10	14.47	37	22986	135754	29793701
Somnolence	29.02	14.47	149	22874	96614	29832841
Cardiac failure	28.87	14.47	14	23009	83404	29846051
Cough	28.23	14.47	33	22990	125609	29803846
Myocardial infarction	28.22	14.47	33	22990	125592	29803863
Foetal alcohol syndrome	27.35	14.47	9	23014	201	29929254
Disease progression	26.75	14.47	14	23009	79860	29849595
Peripheral swelling	26.66	14.47	7	23016	61067	29868388
Pain	26.00	14.47	59	22964	172582	29756873
Product dose omission issue	25.31	14.47	20	23003	91611	29837844
Febrile neutropenia	25.08	14.47	27	22996	106666	29822789
Physical assault	24.86	14.47	14	23009	1199	29928256
Drug intolerance	24.48	14.47	3	23020	45288	29884167
Drug use disorder	24.12	14.47	20	23003	3228	29926227
Impaired driving ability	24.08	14.47	18	23005	2500	29926955
Death	23.52	14.47	395	22628	356888	29572567
Joint swelling	23.31	14.47	4	23019	46942	29882513
Shock	23.11	14.47	53	22970	22806	29906649
Off label use	23.02	14.47	106	22917	249184	29680271
Condition aggravated	22.51	14.47	45	22978	137821	29791634
Oedema peripheral	22.50	14.47	29	22994	105803	29823652
Pneumonia aspiration	22.46	14.47	72	22951	37708	29891747
Tachycardia	22.41	14.47	114	22909	73625	29855830
Gun shot wound	22.34	14.47	13	23010	1185	29928270
Loss of consciousness	22.26	14.47	120	22903	79255	29850200
Metabolic acidosis	21.91	14.47	71	22952	37390	29892065
Asthenia	21.69	14.47	92	22931	221198	29708257
Sepsis	21.25	14.47	51	22972	146344	29783111
Headache	20.96	14.47	71	22952	182235	29747220
Dextrocardia	20.72	14.47	7	23016	170	29929285
Product preparation error	20.47	14.47	14	23009	1692	29927763
Abnormal behaviour	20.19	14.47	54	22969	25569	29903886
Keratitis	20.09	14.47	12	23011	1148	29928307
Drug-induced liver injury	20.06	14.47	48	22975	21226	29908229
Weight decreased	20.04	14.47	55	22968	150866	29778589
White blood cell count decreased	19.99	14.47	21	23002	83926	29845529
General physical health deterioration	18.66	14.47	30	22993	99914	29829541
Somnambulism	18.27	14.47	17	23006	3197	29926258
Mydriasis	18.15	14.47	23	23000	6120	29923335
Respiratory acidosis	17.90	14.47	19	23004	4183	29925272
Urticaria	17.65	14.47	10	23013	54596	29874859
Nausea	17.62	14.47	145	22878	296812	29632643
Alcoholic liver disease	17.40	14.47	9	23014	650	29928805
Pancytopenia	17.36	14.47	24	22999	85028	29844427
Nasopharyngitis	17.34	14.47	12	23011	58837	29870618
Drug interaction	17.10	14.47	231	22792	199337	29730118
Accidental overdose	16.98	14.47	41	22982	18234	29911221
Finger amputation	16.32	14.47	6	23017	188	29929267
Back pain	16.30	14.47	34	22989	102562	29826893
Homicidal ideation	15.91	14.47	14	23009	2449	29927006
Corneal opacity	15.56	14.47	8	23015	571	29928884
Cluster headache	15.52	14.47	8	23015	574	29928881
Paranoia	15.52	14.47	28	22995	10160	29919295
Legal problem	15.51	14.47	6	23017	217	29929238
Decreased appetite	15.49	14.47	61	22962	149849	29779606
Influenza	15.44	14.47	7	23016	43391	29886064
Atrial fibrillation	15.42	14.47	38	22985	108086	29821369
Malaise	15.38	14.47	71	22952	166891	29762564
Dysarthria	15.38	14.47	55	22968	30435	29899020
Product administration error	15.27	14.47	34	22989	14343	29915112
Disturbance in social behaviour	15.16	14.47	11	23012	1460	29927995
Toxicologic test abnormal	15.13	14.47	8	23015	605	29928850
Brain oedema	15.11	14.47	31	22992	12367	29917088
Acute hepatic failure	14.92	14.47	30	22993	11797	29917658
Product use in unapproved indication	14.83	14.47	21	23002	73672	29855783
Haemoglobin decreased	14.82	14.47	42	22981	114056	29815399
Chemical poisoning	14.82	14.47	5	23018	121	29929334
Anion gap	14.73	14.47	8	23015	638	29928817
Drug diversion	14.64	14.47	9	23014	907	29928548

Pharmacologic Action:

Source	Code	Description
ATC	A06AG04	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Enemas
ATC	A06AX01	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Other drugs for constipation
FDA CS	M0000728	Allergens
FDA CS	M0009417	Glycerol
FDA PE	N0000175629	Increased Histamine Release
MeSH PA	D003451	Cryoprotective Agents
MeSH PA	D020011	Protective Agents
MeSH PA	D012997	Solvents
FDA PE	N0000184306	Cell-mediated Immunity
FDA PE	N0000185001	Increased IgG Production
FDA EPC	N0000185370	Non-Standardized Chemical Allergen
CHEBI has role	CHEBI:25728	osmolytes
CHEBI has role	CHEBI:27780	detergents
CHEBI has role	CHEBI:46787	solvents
CHEBI has role	CHEBI:75771	mus musculus metabolite
CHEBI has role	CHEBI:75772	baker's yeast metabolite
CHEBI has role	CHEBI:76971	e.coli metabolites
CHEBI has role	CHEBI:77746	h. sapiens metabolites
CHEBI has role	CHEBI:84735	algal metabolites

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Constipation	indication	14760008	DOID:2089

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:

ID	Source
4017411	VUID
N0000145799	NUI
D00028	KEGG_DRUG
4017411	VANDF
C0017861	UMLSCUI
CHEBI:17754	CHEBI
GOL	PDB_CHEM_ID
CHEMBL692	ChEMBL_ID
DB09462	DRUGBANK_ID
D005990	MESH_DESCRIPTOR_UI
5195	IUPHAR_LIGAND_ID
444	INN_ID
PDC6A3C0OX	UNII
753	PUBCHEM_CID
4910	RXNORM
108842	MMSL
4792	MMSL
52080	MMSL
602	MMSL
d00652	MMSL
001176	NDDF
001893	NDDF
002240	NDDF
002291	NDDF
002469	NDDF
004085	NDDF
404833002	SNOMEDCT_US
80582002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
REFRESH OPTIVE	HUMAN OTC DRUG LABEL	2	0023-3240	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Optive	HUMAN OTC DRUG LABEL	2	0023-3416	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	11 sections
REFRESH OPTIVE Advanced	HUMAN OTC DRUG LABEL	3	0023-4307	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	12 sections
REFRESH OPTIVE Advanced	HUMAN OTC DRUG LABEL	3	0023-4491	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	11 sections
Refresh RELIEVA PF	HUMAN OTC DRUG LABEL	2	0023-4515	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Repair	HUMAN OTC DRUG LABEL	2	0023-4607	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
REFRESH OPTIVE Drops	HUMAN OTC DRUG LABEL	2	0023-5459	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	11 sections
REFRESH OPTIVE Mega-3	HUMAN OTC DRUG LABEL	3	0023-5773	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC monograph final	10 sections
Refresh Repair Preservative-free	HUMAN OTC DRUG LABEL	2	0023-6465	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Relieva	HUMAN OTC DRUG LABEL	2	0023-6630	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Relieva Preservative Free	HUMAN OTC DRUG LABEL	2	0023-6634	SOLUTION/ DROPS	9 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Digital	HUMAN OTC DRUG LABEL	3	0023-6952	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
Refresh Digital PF	HUMAN OTC DRUG LABEL	3	0023-6954	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
REFRESH OPTIVE Mega-3	HUMAN OTC DRUG LABEL	3	0023-7151	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC monograph final	10 sections
Endura	HUMAN PRESCRIPTION DRUG LABEL	2	0023-9235	SOLUTION/ DROPS	1 g	OPHTHALMIC	EXPORT ONLY	1 sections
Refresh RELIEVA PF	HUMAN OTC DRUG LABEL	2	0023-9537	SOLUTION/ DROPS	10 mg	OPHTHALMIC	OTC MONOGRAPH FINULLL	10 sections
GenTeal Tears (Moderate)	HUMAN OTC DRUG LABEL	3	0065-0426	SOLUTION/ DROPS	2 mg	OPHTHALMIC	OTC monograph final	13 sections
Good Sense HemorrhoidalMaximum Strength Pain Relief	HUMAN OTC DRUG LABEL	4	0113-0944	CREAM	14.40 g	TOPICAL	OTC monograph final	15 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0075	SUPPOSITORY	2 g	RECTAL	OTC MONOGRAPH NOT FINULLL	14 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0079	SUPPOSITORY	2 g	RECTAL	OTC MONOGRAPH NOT FINULLL	12 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0079	SUPPOSITORY	2 g	RECTAL	OTC MONOGRAPH NOT FINULLL	12 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0079	SUPPOSITORY	2 g	RECTAL	OTC MONOGRAPH NOT FINULLL	12 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0079	SUPPOSITORY	2 g	RECTAL	OTC MONOGRAPH NOT FINULLL	12 sections
Pedia-Lax	HUMAN OTC DRUG LABEL	1	0132-0081	SUPPOSITORY	1 g	RECTAL	OTC MONOGRAPH NOT FINULLL	11 sections
Fleet	HUMAN OTC DRUG LABEL	1	0132-0185	LIQUID	5.40 g	RECTAL	OTC monograph not final	12 sections
Pedia-Lax	HUMAN OTC DRUG LABEL	1	0132-0190	LIQUID	2.80 g	RECTAL	OTC monograph not final	11 sections
Pedia-Lax	HUMAN OTC DRUG LABEL	1	0132-0195	LIQUID	2.80 g	RECTAL	OTC MONOGRAPH NOT FINULLL	11 sections
ProcalAmine	HUMAN PRESCRIPTION DRUG LABEL	22	0264-1915	INJECTION	3 g	INTRAVENOUS	NDA	24 sections
Walgreens Children GlycerinLaxative	HUMAN OTC DRUG LABEL	1	0363-0440	SUPPOSITORY	83 g	RECTAL	OTC monograph not final	12 sections
Walgreens Children GlycerinLaxative	HUMAN OTC DRUG LABEL	1	0363-0440	SUPPOSITORY	83 g	RECTAL	OTC monograph not final	12 sections