atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution

RxCUI
1190568
RxNorm name
atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
Display name
Atropine/Diphenoxylate (Oral Liquid)
Full name
atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
0.025-2.5 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-08-03 17:32:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
atropine sulfate0.005 MG / 1 MLatropineatropine sulfate
diphenoxylate hydrochloride0.5 MG / 1 MLdiphenoxylatediphenoxylate hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
atropine1223
diphenoxylate3500

Source Vocabulary Codes#

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0054-3194-460054-3194Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine SulfateHikma Pharmaceuticals USA Inc.ANDA087708

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0877080054-3194Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine SulfateANDAHikma Pharmaceuticals USA Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 26 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00054319446rxnav_ndcsyes
52959094960rxnav_ndcsyes
70166063001rxnav_ndcsyes
00014006602rxnav_historical_indirect
00025006602rxnav_historical_indirect
00054817004rxnav_historical_indirect
00054817104rxnav_historical_indirect
00054817116rxnav_historical
00054819116rxnav_historical
00121056404rxnav_historical_indirect
00121056410rxnav_historical_indirect
00121056420rxnav_historical_indirect
00182104743rxnav_historical_indirect
00223654500rxnav_historical_indirect
00247140160rxnav_historical_indirect
00364723658rxnav_historical_indirect
00472099502rxnav_historical_indirect
00570099502rxnav_historical_indirect
00839621464rxnav_historical_indirect
17856319405rxnav_historical
47679042637rxnav_historical_indirect
51432062417rxnav_historical_indirect
52446077152rxnav_historical_indirect
54868151101rxnav_historical_indirect
63874027712rxnav_historical
63874027760rxnav_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
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsExact identifier
ndc (package): 0054-3194-46
ndc (product): 0054-3194
ndc11 (package): 00054319446
rxcui: 1190568

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
88ed4ccf-9e35-4142-a5eb-d2b5edd36956atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSY8Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx only20250612
88ed4ccf-9e35-4142-a5eb-d2b5edd36956atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSN8Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx only20250612
88ed4ccf-9e35-4142-a5eb-d2b5edd36956atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCD8Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx only20250612
cb933606-151e-4fa4-bebe-b11c1ec41100atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCD2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20190910
cb933606-151e-4fa4-bebe-b11c1ec41100atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSY2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20190910
cb933606-151e-4fa4-bebe-b11c1ec41100atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSN2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20190910
b0c91667-ab6f-481d-a592-62da8a52abf7atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSY2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20171220
b0c91667-ab6f-481d-a592-62da8a52abf7atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCD2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20171220
b0c91667-ab6f-481d-a592-62da8a52abf7atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSN2Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV20171220

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
88ed4ccf-9e35-4142-a5eb-d2b5edd36956Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx onlyHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.20250626
88ed4ccf-9e35-4142-a5eb-d2b5edd36956Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx onlyHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.20250612
cb933606-151e-4fa4-bebe-b11c1ec41100Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CVLohxa20190910
b0c91667-ab6f-481d-a592-62da8a52abf7Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CVAtlantic Biologicals Corps20171220
7a17f727-3f97-4c86-8c29-406cdc172fe6National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01FAAnticholinergicsATC1-4atropine
ATCA07DAAntipropulsivesATC1-4diphenoxylate
ATCA03BABelladonna alkaloids, tertiary aminesATC1-4atropine
FDASPLN0000175574AnticholinergicEPChas_epcatropine
FDASPLN0000178374AntidiarrhealEPChas_epcdiphenoxylate
FDASPLN0000175700Cholinergic Muscarinic AntagonistEPChas_epcatropine
FDASPLN0000175370Cholinergic AntagonistsMOAhas_moaatropine
FDASPLN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine
MEDRTD001285AtropineCHEMhas_ingredientatropine sulfate
MEDRTD004157DiphenoxylateCHEMhas_ingredientdiphenoxylate
MEDRTD004157DiphenoxylateCHEMhas_ingredientdiphenoxylate hydrochloride
MEDRTD001249AsthmaDISEASEci_withatropine sulfate
MEDRTD001249AsthmaDISEASEci_withatropine
MEDRTD001919BradycardiaDISEASEmay_treatatropine
MEDRTD001919BradycardiaDISEASEmay_treatatropine sulfate
MEDRTD002675Child, PreschoolDISEASEci_withdiphenoxylate
MEDRTD002675Child, PreschoolDISEASEci_withdiphenoxylate hydrochloride
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine sulfate
MEDRTD003093Colitis, UlcerativeDISEASEci_withatropine
MEDRTD003681DehydrationDISEASEci_withdiphenoxylate
MEDRTD003681DehydrationDISEASEci_withdiphenoxylate hydrochloride
MEDRTD003967DiarrheaDISEASEci_withdiphenoxylate hydrochloride
MEDRTD003967DiarrheaDISEASEmay_treatdiphenoxylate hydrochloride
MEDRTD003967DiarrheaDISEASEmay_treatdiphenoxylate
MEDRTD003967DiarrheaDISEASEci_withdiphenoxylate
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenoxylate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine sulfate
MEDRTD004342Drug HypersensitivityDISEASEci_withatropine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenoxylate hydrochloride
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine sulfate
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatatropine
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withdiphenoxylate
MEDRTD004761Enterocolitis, PseudomembranousDISEASEci_withdiphenoxylate hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine sulfate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withatropine
MEDRTD006323Heart ArrestDISEASEmay_treatatropine sulfate
MEDRTD006323Heart ArrestDISEASEmay_treatatropine
MEDRTD006327Heart BlockDISEASEci_withatropine
MEDRTD006327Heart BlockDISEASEci_withatropine sulfate
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine
MEDRTD007415Intestinal ObstructionDISEASEci_withatropine sulfate
MEDRTD007499Iris DiseasesDISEASEci_withatropine
MEDRTD007499Iris DiseasesDISEASEci_withatropine sulfate
MEDRTD007565JaundiceDISEASEci_withdiphenoxylate
MEDRTD007565JaundiceDISEASEci_withdiphenoxylate hydrochloride
MEDRTD007674Kidney DiseasesDISEASEci_withatropine
MEDRTD007674Kidney DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine sulfate
MEDRTD007905Lens DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withdiphenoxylate
MEDRTD008107Liver DiseasesDISEASEci_withatropine sulfate
MEDRTD008107Liver DiseasesDISEASEci_withatropine
MEDRTD008107Liver DiseasesDISEASEci_withdiphenoxylate hydrochloride
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine
MEDRTD008532Megacolon, ToxicDISEASEci_withatropine sulfate
MEDRTD009157Myasthenia GravisDISEASEci_withatropine
MEDRTD009157Myasthenia GravisDISEASEci_withatropine sulfate
MEDRTD015878MydriasisDISEASEinducesatropine sulfate
MEDRTD015878MydriasisDISEASEinducesatropine
MEDRTD011041PoisoningDISEASEmay_treatatropine
MEDRTD011041PoisoningDISEASEmay_treatatropine sulfate
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine
MEDRTD012848Sinoatrial BlockDISEASEmay_treatatropine sulfate
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine sulfate
MEDRTD013276Stomach UlcerDISEASEmay_treatatropine
MEDRTD013610TachycardiaDISEASEci_withatropine sulfate
MEDRTD013610TachycardiaDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine
MEDRTD013971ThyrotoxicosisDISEASEci_withatropine sulfate
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine
MEDRTD000267Tissue AdhesionsDISEASEci_withatropine sulfate
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine sulfate
MEDRTD014517Ureteral ObstructionDISEASEci_withatropine
MEDRTD014605UveitisDISEASEmay_treatatropine sulfate
MEDRTD014605UveitisDISEASEmay_treatatropine
MEDRTD014987XerostomiaDISEASEinducesatropine sulfate
MEDRTD014987XerostomiaDISEASEinducesatropine
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine sulfate
MEDRTN0000000125Cholinergic Muscarinic AntagonistsMOAhas_moaatropine
MEDRTN0000008635Decreased GI MotilityPEhas_pediphenoxylate
MEDRTN0000008635Decreased GI MotilityPEhas_pediphenoxylate hydrochloride
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine
MEDRTN0000008779Decreased Parasympathetic Acetylcholine ActivityPEhas_peatropine sulfate
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine
MEDRTN0000008868Decreased Respiratory SecretionsPEhas_peatropine sulfate
MEDRTN0000009808Positive ChronotropyPEhas_peatropine
MEDRTN0000009808Positive ChronotropyPEhas_peatropine sulfate
MEDRTN0000009820Pupillary DilationPEhas_peatropine
MEDRTN0000009820Pupillary DilationPEhas_peatropine sulfate
MEDRTN0000009842Salivation InhibitionPEhas_peatropine
MEDRTN0000009842Salivation InhibitionPEhas_peatropine sulfate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.005 MG/ML / 0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE5
ATTRIBUTESTTYSCD
CODESANDAANDA087708
CODESMMSL_CODEBD672
CODESMMSL_CODECD672
CODESRxCUI1190568
CODESSPL_SET_ID88ed4ccf-9e35-4142-a5eb-d2b5edd36956
CODESVUID4002628
NAMESPrescribable Synonymatropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution
NAMESRXNAV_STRatropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
NAMESRxNorm Nameatropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution
NAMESRxNorm Synonymatropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File