FDA.reportPublic FDA data

acetaminophen 500 MG Oral Tablet [Cetafen]

RxCUI
1358835
RxNorm name
acetaminophen 500 MG Oral Tablet [Cetafen]
Display name
CETAFEN (Oral Pill)
Full name
acetaminophen 500 MG Oral Tablet [Cetafen]
Term type
SBD
Status
Active
Strength
500 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:55:20

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122012
Active start
122012
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

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

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRCetafen 500 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 500 MG Oral Tablet [Cetafen]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID38db0b09-37f8-4fed-903e-81e89486b39b1CODES
RxCUI13588351CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50332-0149-150332-0149CETAFEN EXTRA acetaminophenHART HealthM
50332-0149-350332-0149CETAFEN EXTRA acetaminophenHART HealthM
50332-0149-450332-0149CETAFEN EXTRA acetaminophenHART HealthM
50332-0149-750332-0149CETAFEN EXTRA acetaminophenHART HealthM
50332-0149-850332-0149CETAFEN EXTRA acetaminophenHART HealthM

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M50332-0149CETAFEN EXTRA acetaminophenOTC MONOGRAPH DRUGHART Health

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50332010801rxnav_ndcsyes
50332010804rxnav_ndcsyes
50332010807rxnav_ndcsyes
50332010808rxnav_ndcsyes
50332014901rxnav_ndcsyes
50332014903rxnav_ndcsyes
50332014904rxnav_ndcsyes
50332014907rxnav_ndcsyes
50332014908rxnav_ndcsyes
50332010803rxnav_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
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
ndc (package): 50332-0149-7
ndc (package): 50332-0149-4
ndc (package): 50332-0149-3
ndc (package): 50332-0149-8
ndc (package): 50332-0149-1
ndc (product): 50332-0149
ndc11 (package): 50332014907
ndc11 (package): 50332014901
ndc11 (package): 50332014904
ndc11 (package): 50332014908
ndc11 (package): 50332014903
rxcui: 1358835

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
38db0b09-37f8-4fed-903e-81e89486b39bCetafen Extra 500 MG Oral Tablet [PSN] · acetaminophen 500 MG Oral Tablet [Cetafen] [SBD] · APAP 500 MG Oral Tablet [Cetafen] [SY] · Cetafen 500 MG Oral Tablet [SY]43CETAFEN EXTRA20251224
207cf327-b35c-405c-979e-af25183e6ae5Cetafen Extra 500 MG Oral Tablet [PSN] · acetaminophen 500 MG Oral Tablet [Cetafen] [SBD] · APAP 500 MG Oral Tablet [Cetafen] [SY] · Cetafen 500 MG Oral Tablet [SY]41CETAFEN EXTRA20121111

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
38db0b09-37f8-4fed-903e-81e89486b39bCETAFEN EXTRAHART Health20251224
207cf327-b35c-405c-979e-af25183e6ae5CETAFEN EXTRAHART Health20121111

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH500 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymCetafen Extra 500 MG Oral Tablet
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK