FDA.reportPublic FDA data

acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet

RxCUI
1250743
RxNorm name
acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
Display name
Acetaminophen/Dextromethorphan/Pseudoephedrine (Oral Pill)
Full name
acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500-15-30 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-19 06:53:45

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052012
Active start
052012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
dextromethorphan hydrobromide15 MG / 1 EACHdextromethorphandextromethorphan hydrobromide
pseudoephedrine hydrochloride30 MG / 1 EACHpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dextromethorphan3289
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletNAMES
RxNorm Nameacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletNAMES
RxNorm SynonymAPAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID712ba011-79aa-469b-9f0f-04a0b4b705bdCODES
SPL_SET_ID7d3266dc-879a-4d28-b8ea-74d238c3020aCODES
RxCUI1250743CODES
MMSL_CODEBD4415CODES
MMSL_CODECD4415CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-344-0150580-344Extra Strength TYLENOL Cold Plus Flu Multi-Action acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan HydrobromideKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-344Extra Strength TYLENOL Cold Plus Flu Multi-Action acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan HydrobromideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
50580034401rxnav_ndcsyes
00043047612rxnav_historical
00043047624rxnav_historical
00045084110rxnav_historical_indirect
00045084112rxnav_historical_indirect
00045084120rxnav_historical_indirect
00045084124rxnav_historical_indirect
00067047624rxnav_historical_indirect
00067447612rxnav_historical_indirect
00067447624rxnav_historical_indirect
00067611012rxnav_historical
00067611024rxnav_historical
00067611112rxnav_historical_indirect
00081077313rxnav_historical_indirect
00081077320rxnav_historical_indirect
00081080213rxnav_historical_indirect
00081080220rxnav_historical_indirect
00081960001rxnav_historical_indirect
00081960002rxnav_historical_indirect
00081960003rxnav_historical_indirect
00501277012rxnav_historical_indirect
00501277320rxnav_historical_indirect
00501280012rxnav_historical_indirect
00501280024rxnav_historical_indirect
10916033710rxnav_historical_indirect
10916034310rxnav_historical_indirect
11822349350rxnav_historical
19810004101rxnav_historical_indirect
37205085960rxnav_historical
41163059653rxnav_historical
41163059662rxnav_historical
45800023816rxnav_historical_indirect
49035026762rxnav_historical
49348007101rxnav_historical
49348086601rxnav_historical_indirect
50580084112rxnav_historical_indirect
50580084124rxnav_historical_indirect
52297057852rxnav_historical_indirect

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7d3266dc-879a-4d28-b8ea-74d238c3020aacetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN8Extra Strength TYLENOL Cold + Flu Multi-Action Day20241107
7d3266dc-879a-4d28-b8ea-74d238c3020aacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD8Extra Strength TYLENOL Cold + Flu Multi-Action Day20241107
7d3266dc-879a-4d28-b8ea-74d238c3020aAPAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY8Extra Strength TYLENOL Cold + Flu Multi-Action Day20241107
712ba011-79aa-469b-9f0f-04a0b4b705bdacetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN6Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night20241108
712ba011-79aa-469b-9f0f-04a0b4b705bdAPAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY6Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night20241108
712ba011-79aa-469b-9f0f-04a0b4b705bdacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD6Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night20241108

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7d3266dc-879a-4d28-b8ea-74d238c3020aExtra Strength TYLENOL Cold + Flu Multi-Action DayKenvue Brands LLC20241107

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine hydrochloride
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG / 15 MG / 30 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD4415
CODESMMSL_CODECD4415
CODESRxCUI1250743
CODESSPL_SET_ID712ba011-79aa-469b-9f0f-04a0b4b705bd
CODESSPL_SET_ID7d3266dc-879a-4d28-b8ea-74d238c3020a
CODESVUID4010199
CODESVUID4030972
NAMESPrescribable Synonymacetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet
NAMESRXNAV_STRacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
NAMESRxNorm Nameacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
NAMESRxNorm SynonymAPAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet
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