FDA.reportPublic FDA data

atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]

RxCUI
1046978
RxNorm name
atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]
Display name
DONNATAL (Oral Pill)
Full name
atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]
Term type
SBD
Status
Active
Strength
0.0194-0.1037-16.2-0.0065 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-08-03 17:29:35

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate0.0194 MG / 1 EACHatropineatropine sulfate
hyoscyamine sulfate0.1037 MG / 1 EACHhyoscyaminehyoscyamine sulfate
phenobarbital16.2 MG / 1 EACHphenobarbitalphenobarbital
scopolamine hydrobromide0.0065 MG / 1 EACHscopolaminescopolamine hydrobromide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223
hyoscyamine153970
phenobarbital8134
scopolamine9601

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRDonnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet1NAMES
RxNorm Nameatropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]1NAMES
RxNorm SynonymDonnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDc93cccdc-2f92-4cb3-9d14-06acdd51d94c1CODES
RxCUI10469781CODES
MMSL_CODEBD8281CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59212-425-0459212-425Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.
59212-425-1059212-425Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 18 matching rows.

NDC11, Source, Active table
NDC11SourceActive
42291024501rxnav_ndcsyes
43063060101rxnav_ndcsyes
59212042504rxnav_ndcsyes
59212042510rxnav_ndcsyes
66213042510rxnav_ndcsyes
66213042511rxnav_ndcsyes
00031425063rxnav_historical
00031425064rxnav_historical
00031425074rxnav_historical
00179013270rxnav_historical
42254026820rxnav_historical
53978343709rxnav_historical
54868123700rxnav_historical
54868123701rxnav_historical
54868123702rxnav_historical
59212042511rxnav_historical
65084012310rxnav_historical
68151060701rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEAdvanz Pharma (US) Corp.c93cccdc-2f92-4cb3-9d14-06acdd51d94c2024-12-05Warnings, Adverse reactionsExact identifier
ndc (package): 59212-425-04
ndc (package): 59212-425-10
ndc (product): 59212-425
ndc11 (package): 59212042511
ndc11 (package): 59212042504
ndc11 (package): 59212042510
rxcui: 1046978

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c93cccdc-2f92-4cb3-9d14-06acdd51d94cDonnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet [PSN] · atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal] [SBD] · Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet [SY]314DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx Only Revised: 11/2320241205
54f28743-bb66-4234-8d20-8502a5ffdc26Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet [PSN] · atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal] [SBD] · Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet [SY]33Donnatal Tablets20131203
7343cfab-9bd9-4dcb-bbef-9592ffd5d7e6Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet [PSN] · atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal] [SBD] · Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet [SY]32Donnatal Tablets20131203
1cc18146-d9be-4975-89ba-e99a85f71c76Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet [PSN] · atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal] [SBD] · Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet [SY]31Donnatal Tablets20120731

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c93cccdc-2f92-4cb3-9d14-06acdd51d94cDONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx Only Revised: 11/23Advanz Pharma (US) Corp.20241205
935b19ba-1e17-99c3-6c22-1e21fd8263dfDONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablets Rx OnlyAvKARE20220113
54f28743-bb66-4234-8d20-8502a5ffdc26Donnatal TabletsPBM Pharmaceuticals Inc. | IriSys, Inc.20131203
7343cfab-9bd9-4dcb-bbef-9592ffd5d7e6Donnatal TabletsCarilion Materials Management20131203
0464fc99-ba7a-406c-9164-da5d45795a5fNational Council for Prescription Drug Programs20130213
1cc18146-d9be-4975-89ba-e99a85f71c76Donnatal TabletsRebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.20120731
2253fdfa-3f16-4c8c-95db-8ad7819b26eaNational Council for Prescription Drug Programs20120724
578d697b-9dd6-47bc-96ce-253256e0a8a2National Council for Prescription Drug Programs20120724
794fa347-8ad1-4083-a4a1-d6cacca7221dNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4scopolamine
ATCS01FAAnticholinergicsATC1-4atropine
ATCN03AABarbiturates and derivativesATC1-4phenobarbital
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4atropine
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4hyoscyamine
ATCA04ADOther antiemeticsATC1-4scopolamine
ATCN05CMOther hypnotics and sedativesATC1-4scopolamine
FDASPLN0000175574AnticholinergicEPChas_epcscopolamine
FDASPLN0000175574AnticholinergicEPChas_epcatropine
FDASPLN0000175700Cholinergic Muscarinic AntagonistEPChas_epcatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moaatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moascopolamine
FDASPLN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine sulfate
MEDRTD064692HyoscyamineCHEMhas_ingredienthyoscyamine
MEDRTD064692HyoscyamineCHEMhas_ingredienthyoscyamine sulfate
MEDRTD010634PhenobarbitalCHEMhas_ingredientphenobarbital
MEDRTD012601ScopolamineCHEMhas_ingredientscopolamine
MEDRTD012601ScopolamineCHEMhas_ingredientscopolamine hydrobromide
MEDRTD000014Abnormalities, Drug-InducedDISEASEmay_treathyoscyamine sulfate
MEDRTD000014Abnormalities, Drug-InducedDISEASEmay_treathyoscyamine
MEDRTD000402Airway ObstructionDISEASEci_withphenobarbital
MEDRTD000647AmnesiaDISEASEinducesscopolamine
MEDRTD000647AmnesiaDISEASEinducesscopolamine hydrobromide
MEDRTD001249AsthmaDISEASEci_withatropine
MEDRTD001249AsthmaDISEASEci_withatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine sulfate
MEDRTD001919BradycardiaDISEASEmay_treatatropine
MEDRTD003085ColicDISEASEmay_treathyoscyamine
MEDRTD003085ColicDISEASEmay_treathyoscyamine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withhyoscyamine
MEDRTD003093Colitis, UlcerativeDISEASEci_withhyoscyamine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine sulfate
MEDRTD003108Colonic DiseasesDISEASEmay_treatscopolamine
MEDRTD003108Colonic DiseasesDISEASEmay_treatscopolamine hydrobromide
MEDRTD004238DiverticulitisDISEASEmay_treatscopolamine hydrobromide
MEDRTD004238DiverticulitisDISEASEmay_treatscopolamine
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withphenobarbital
MEDRTD004342Drug HypersensitivityDISEASEci_withscopolamine
MEDRTD004342Drug HypersensitivityDISEASEci_withscopolamine hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withhyoscyamine
MEDRTD004342Drug HypersensitivityDISEASEci_withhyoscyamine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine sulfate
MEDRTD004403DysenteryDISEASEmay_treatscopolamine
MEDRTD004403DysenteryDISEASEmay_treatscopolamine hydrobromide
MEDRTD004828Epilepsies, PartialDISEASEmay_treatphenobarbital
MEDRTD020936Epilepsy, Benign NeonatalDISEASEmay_treatphenobarbital
MEDRTD004830Epilepsy, Tonic-ClonicDISEASEmay_treatphenobarbital
MEDRTD005158Facial ParalysisDISEASEmay_treatscopolamine
MEDRTD005158Facial ParalysisDISEASEmay_treatscopolamine hydrobromide
MEDRTD018589GastroparesisDISEASEinduceshyoscyamine sulfate
MEDRTD018589GastroparesisDISEASEinduceshyoscyamine
MEDRTD005901GlaucomaDISEASEci_withhyoscyamine
MEDRTD005901GlaucomaDISEASEci_withhyoscyamine sulfate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withscopolamine hydrobromide
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withscopolamine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine
MEDRTD006327Heart BlockDISEASEci_withatropine
MEDRTD006327Heart BlockDISEASEci_withatropine sulfate
MEDRTD006470HemorrhageDISEASEci_withscopolamine
MEDRTD006470HemorrhageDISEASEci_withscopolamine hydrobromide
MEDRTD006932HyperbilirubinemiaDISEASEmay_treatphenobarbital
MEDRTD006945HyperhidrosisDISEASEmay_treathyoscyamine sulfate
MEDRTD006945HyperhidrosisDISEASEmay_treathyoscyamine
MEDRTD007077Ileal DiseasesDISEASEci_withhyoscyamine sulfate
MEDRTD007077Ileal DiseasesDISEASEci_withhyoscyamine
MEDRTD007415Intestinal ObstructionDISEASEci_withhyoscyamine sulfate
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withhyoscyamine
MEDRTD007415Intestinal ObstructionDISEASEci_withscopolamine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine sulfate
MEDRTD007415Intestinal ObstructionDISEASEci_withscopolamine hydrobromide
MEDRTD007431Intraoperative ComplicationsDISEASEmay_treathyoscyamine sulfate
MEDRTD007431Intraoperative ComplicationsDISEASEmay_treathyoscyamine
MEDRTD015863IridocyclitisDISEASEmay_treatscopolamine
MEDRTD015863IridocyclitisDISEASEmay_treatscopolamine hydrobromide
MEDRTD007499Iris DiseasesDISEASEci_withatropine
MEDRTD007499Iris DiseasesDISEASEci_withatropine sulfate
MEDRTD043183Irritable Bowel SyndromeDISEASEmay_treathyoscyamine
MEDRTD043183Irritable Bowel SyndromeDISEASEmay_treathyoscyamine sulfate
MEDRTD007674Kidney DiseasesDISEASEci_withatropine
MEDRTD007674Kidney DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withatropine sulfate
MEDRTD017093Liver FailureDISEASEci_withphenobarbital
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withhyoscyamine sulfate
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine
MEDRTD008532Megacolon, ToxicDISEASEci_withhyoscyamine
MEDRTD009041Motion SicknessDISEASEmay_preventscopolamine hydrobromide
MEDRTD009041Motion SicknessDISEASEmay_preventscopolamine
MEDRTD009127Muscle RigidityDISEASEmay_treathyoscyamine sulfate
MEDRTD009127Muscle RigidityDISEASEmay_treathyoscyamine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine
MEDRTD009157Myasthenia GravisDISEASEci_withhyoscyamine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withscopolamine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withhyoscyamine
MEDRTD009157Myasthenia GravisDISEASEci_withscopolamine hydrobromide
MEDRTD015878MydriasisDISEASEinducesscopolamine hydrobromide
MEDRTD015878MydriasisDISEASEinducesscopolamine
MEDRTD015878MydriasisDISEASEinducesatropine
MEDRTD015878MydriasisDISEASEinducesatropine sulfate
MEDRTD017202Myocardial IschemiaDISEASEci_withhyoscyamine
MEDRTD017202Myocardial IschemiaDISEASEci_withhyoscyamine sulfate
MEDRTD009325NauseaDISEASEmay_preventscopolamine hydrobromide
MEDRTD009325NauseaDISEASEmay_preventscopolamine
MEDRTD010301Parkinson Disease, PostencephaliticDISEASEmay_treatscopolamine
MEDRTD010301Parkinson Disease, PostencephaliticDISEASEmay_treatscopolamine hydrobromide
MEDRTD010437Peptic UlcerDISEASEmay_treathyoscyamine sulfate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE4
NAMESPrescribable SynonymDonnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral Tablet
NAMESTallman Synonymatropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]
NAMESTallman SynonymDonnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon