FDA.reportPublic FDA data

acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet

RxCUI
1798453
RxNorm name
acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet
Display name
Acetaminophen/Dexbrompheniramine (Oral Pill)
Full name
acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500-1 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-24 12:45:39

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082016
Active start
082016
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
dexbrompheniramine maleate1 MG / 1 EACHdexbrompheniraminedexbrompheniramine maleate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dexbrompheniramine22696

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI17984531CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
54859-001-0154859-001Dologesic Acetaminophen, Dexbrompheniramine MaleateLlorens Pharmaceutical International DivisionM012
54859-001-5054859-001Dologesic Acetaminophen, Dexbrompheniramine MaleateLlorens Pharmaceutical International DivisionM012
54859-010-0154859-010Dologesic Acetaminophen, Dexbrompheniramine MaleateLlorens Pharmaceutical International DivisionM012
63102-402-1063102-402ACTIDOGESIC Dexbrompheniramine maleate, acetaminophenACTIPHARMA, LLCM012
63102-403-1063102-403ACTIDOGESIC DF Acetaminophen, Dexbrompheniramine MaleateACTIPHARMA, LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01254859-001Dologesic Acetaminophen, Dexbrompheniramine MaleateOTC MONOGRAPH DRUGLlorens Pharmaceutical International Division

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
54859000101rxnav_ndcsyes
54859000105rxnav_ndcsyes
54859000150rxnav_ndcsyes
54859001001rxnav_ndcsyes
63102040210rxnav_ndcsyes
63102040310rxnav_ndcsyes
45737061010rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
ndc (package): 54859-001-01
ndc (package): 54859-001-50
ndc (product): 54859-001
ndc11 (package): 54859000101
ndc11 (package): 54859000150
rxcui: 1798453
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
ndc (package): 54859-010-01
ndc (product): 54859-010
ndc11 (package): 54859001001
rxcui: 1798453
ACTIDOGESICDEXBROMPHENIRAMINE MALEATE, ACETAMINOPHENACTIPHARMA, LLC697da3f9-9888-4d41-ba83-87ca9bf1e54b2025-08-18WarningsExact identifier
ndc (package): 63102-402-10
ndc (product): 63102-402
ndc11 (package): 63102040210
rxcui: 1798453
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
ndc (package): 63102-403-10
ndc (product): 63102-403
ndc11 (package): 63102040310
rxcui: 1798453

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
974fc0d5-7a99-46fb-af38-b91240f728faacetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [PSN] · acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [SCD] · APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet [SY]38Llorens-Dologesic 00120251231
55768b45-fd98-4779-85b6-6a50c628677eacetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [PSN] · acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [SCD] · APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet [SY]37Llorens-DologesicDFTab 01020251231
697da3f9-9888-4d41-ba83-87ca9bf1e54bacetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [PSN] · acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [SCD] · APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet [SY]35ACTIDOGESIC ®20250818
ff8e2565-bce3-4c06-a416-6e8f369f057facetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [PSN] · acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [SCD] · APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet [SY]35ACTIDOGESIC ® - DF20250709
fdfebc9f-4775-4da4-9bb0-8175e67f93c4acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [PSN] · acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet [SCD] · APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet [SY]33AGC-Biogesic Tab 61020241220

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
974fc0d5-7a99-46fb-af38-b91240f728faLlorens-Dologesic 001Llorens Pharmaceutical International Division20251231
55768b45-fd98-4779-85b6-6a50c628677eLlorens-DologesicDFTab 010Llorens Pharmaceutical International Division20251231
697da3f9-9888-4d41-ba83-87ca9bf1e54bACTIDOGESIC ®ACTIPHARMA, LLC20250818
ff8e2565-bce3-4c06-a416-6e8f369f057fACTIDOGESIC ® - DFACTIPHARMA, LLC20250709
fdfebc9f-4775-4da4-9bb0-8175e67f93c4AGC-Biogesic Tab 610Advanced Generic Corporation20241220

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCR06ABSubstituted alkylaminesATC1-4dexbrompheniramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine maleate
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine maleate
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine maleate
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine
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 / 1 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4035860
NAMESPrescribable Synonymacetaminophen 500 MG / dexbrompheniramine maleate 1 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