FDA.reportPublic FDA data

acetaminophen 500 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet

RxCUI
1090743
RxNorm name
acetaminophen 500 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
Display name
Acetaminophen/Pseudoephedrine (Oral Pill)
Full name
acetaminophen 500 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500-30 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:45:13

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032011
Active start
032011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
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
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 500 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 500 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 500 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10907431CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-659-1050580-659Sudafed Sinus Congestion Plus Cold Severe Day Acetaminophen, PseudoephedrineKenvue Brands LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250580-659Sudafed Sinus Congestion Plus Cold Severe Day Acetaminophen, PseudoephedrineOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 102 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00225060008rxnav_ndcsyes
00363023708rxnav_ndcsyes
11868023716rxnav_ndcsyes
11868023732rxnav_ndcsyes
24385048862rxnav_ndcsyes
50580065910rxnav_ndcsyes
52735045005rxnav_ndcsyes
00043014224rxnav_historical_indirect
00043047824rxnav_historical_indirect
00045019124rxnav_historical_indirect
00045019150rxnav_historical_indirect
00045029024rxnav_historical_indirect
00045029050rxnav_historical_indirect
00045029055rxnav_historical_indirect
00045038120rxnav_historical_indirect
00045038140rxnav_historical_indirect
00045040542rxnav_historical_indirect
00045040550rxnav_historical_indirect
00045043224rxnav_historical_indirect
00045043250rxnav_historical_indirect
00045047324rxnav_historical_indirect
00045047350rxnav_historical_indirect
00045047360rxnav_historical_indirect
00045048020rxnav_historical_indirect
00045048040rxnav_historical_indirect
00067014024rxnav_historical_indirect
00067014224rxnav_historical_indirect
00081076624rxnav_historical_indirect
00081076648rxnav_historical_indirect
00081076824rxnav_historical_indirect
00081076848rxnav_historical_indirect
00182214516rxnav_historical_indirect
00225060004rxnav_historical_indirect
00501220724rxnav_historical_indirect
00501274024rxnav_historical_indirect
00501275024rxnav_historical_indirect
00501276624rxnav_historical_indirect
00501276648rxnav_historical_indirect
00501276824rxnav_historical_indirect
00501276848rxnav_historical_indirect
00573112021rxnav_historical_indirect
00573112031rxnav_historical_indirect
00839741701rxnav_historical_indirect
00904795424rxnav_historical_indirect
10916030824rxnav_historical_indirect
11370011412rxnav_historical_indirect
11845086607rxnav_historical_indirect
11917004155rxnav_historical
12547017170rxnav_historical_indirect
12547036425rxnav_historical_indirect
12547036448rxnav_historical_indirect
12547036454rxnav_historical_indirect
12547364850rxnav_historical_indirect
12843012813rxnav_historical_indirect
12843012814rxnav_historical_indirect
12843017829rxnav_historical_indirect
12843128130rxnav_historical_indirect
12843128140rxnav_historical_indirect
19810007701rxnav_historical_indirect
19810007702rxnav_historical_indirect
19810007704rxnav_historical_indirect
19810007720rxnav_historical_indirect
19810007740rxnav_historical_indirect
19810008001rxnav_historical_indirect
19810008002rxnav_historical_indirect
19810008007rxnav_historical_indirect
19810008070rxnav_historical_indirect
24385043862rxnav_historical
24385064362rxnav_historical
37205037462rxnav_historical
37205037662rxnav_historical
37205044762rxnav_historical
41163001762rxnav_historical
41163007762rxnav_historical
41163022862rxnav_historical
41163041062rxnav_historical
41163043862rxnav_historical
45800023924rxnav_historical_indirect
45800025324rxnav_historical_indirect
45800026920rxnav_historical_indirect
49035043862rxnav_historical
49035043867rxnav_historical
49348029704rxnav_historical
49348085804rxnav_historical
49348086004rxnav_historical
50580029024rxnav_historical_indirect
50580029048rxnav_historical_indirect
50580043224rxnav_historical_indirect
50580043248rxnav_historical_indirect
50580043272rxnav_historical_indirect
50580048020rxnav_historical_indirect
50580048048rxnav_historical_indirect
52297043862rxnav_historical
52297059062rxnav_historical_indirect
52297059762rxnav_historical_indirect
52735044105rxnav_historical_indirect
58716075400rxnav_historical_indirect
70030043862rxnav_historical_indirect
87900092924rxnav_historical_indirect
87900092948rxnav_historical_indirect
95814027012rxnav_historical_indirect
95814027024rxnav_historical_indirect

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sudafed Sinus Congestion Plus Cold Severe DayACETAMINOPHEN, PSEUDOEPHEDRINEKenvue Brands LLC537e1a0d-820d-c3f7-e063-6294a90a56ea2026-06-10WarningsExact identifier
ndc (package): 50580-659-10
ndc (product): 50580-659
ndc11 (package): 50580065910
rxcui: 1090743
Sudafed Sinus Congestion plus Cold Severe Day and NightACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINEKenvue Brands LLC5382dcad-0337-4440-e063-6394a90a706e2026-06-10WarningsExact identifier
rxcui: 1090743

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 · 0 matching rows.

No records found.

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
537e1a0d-820d-c3f7-e063-6294a90a56eaSudafed Sinus Congestion + Cold Severe DayKenvue Brands LLC20260610

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
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 / 30 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESSNOMEDCT408076008
CODESVUID4008906
NAMESPrescribable Synonymacetaminophen 500 MG / pseudoephedrine HCl 30 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File