acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet

RxCUI
1099872
RxNorm name
acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet
Display name
Acetaminophen/diphenhydrAMINE (Oral Pill)
Full name
acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500-38 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:45:23

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052011
Active start
052011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
diphenhydramine citrate38 MG / 1 EACHdiphenhydraminediphenhydramine citrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
diphenhydramine3498

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 500 MG / Diphenhydramine Citrate 38 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID403a88fa-e06b-9b6e-e063-6394a90a97b81CODES
RxCUI10998721CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
57631-010-0057631-010Acetaminophen and Diphenhydramine citrate Acetaminophen and Diphenhydramine citrateInvaTech Pharma Solutions LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01257631-010Acetaminophen and Diphenhydramine citrate Acetaminophen and Diphenhydramine citrateOTC MONOGRAPH DRUGInvaTech Pharma Solutions LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 58 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00280807020rxnav_ndcsyes
00363037312rxnav_ndcsyes
12843053711rxnav_ndcsyes
57631001000rxnav_ndcsyes
00067205324rxnav_historical_indirect
00067205350rxnav_historical_indirect
00067205391rxnav_historical_indirect
00067205524rxnav_historical_indirect
00067205550rxnav_historical_indirect
00067205591rxnav_historical_indirect
01981000323rxnav_historical_indirect
01981000325rxnav_historical_indirect
01981000326rxnav_historical_indirect
01981007634rxnav_historical_indirect
01981007643rxnav_historical_indirect
11673037312rxnav_historical
11822037302rxnav_historical
11822574290rxnav_historical
11917007220rxnav_historical
19810000183rxnav_historical_indirect
19810000240rxnav_historical_indirect
19810000322rxnav_historical_indirect
19810000323rxnav_historical_indirect
19810000326rxnav_historical_indirect
19810001801rxnav_historical_indirect
19810001802rxnav_historical_indirect
19810001803rxnav_historical_indirect
19810001804rxnav_historical_indirect
19810003202rxnav_historical_indirect
19810003203rxnav_historical_indirect
19810003206rxnav_historical_indirect
19810007067rxnav_historical_indirect
19810007068rxnav_historical_indirect
19810008401rxnav_historical_indirect
19810008402rxnav_historical_indirect
19810076303rxnav_historical_indirect
19810076304rxnav_historical_indirect
19810076305rxnav_historical_indirect
19810076306rxnav_historical_indirect
19810076309rxnav_historical_indirect
21130037315rxnav_historical
33992037300rxnav_historical
33992037308rxnav_historical
33992037309rxnav_historical
41163037312rxnav_historical
49348007209rxnav_historical
50428322867rxnav_historical
55301037315rxnav_historical
55301097315rxnav_historical
55910037315rxnav_historical
59779037308rxnav_historical
59779037312rxnav_historical
63868015901rxnav_historical
63868015912rxnav_historical
63941037315rxnav_historical
68210002003rxnav_historical
68210200002rxnav_historical
68210413502rxnav_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
Acetaminophen and Diphenhydramine citrateACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEInvaTech Pharma Solutions LLC403a88fa-e06b-9b6e-e063-6394a90a97b82025-10-02WarningsExact identifier
ndc (package): 57631-010-00
ndc (product): 57631-010
ndc11 (package): 57631001000
rxcui: 1099872

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d9d22e45-1a13-4b45-910d-1183a8e6ed7dacetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 500 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]36Headache PM (Aspirin Free)20241230
e5e73f9d-7927-4b7f-be6c-cb8aeda21beeacetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 500 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]35Assured™ Headache PM (Aspirin Free)20220113
403a88fa-e06b-9b6e-e063-6394a90a97b8acetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 500 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]34Acetaminophen and Diphenhydramine citrate20251002

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
403a88fa-e06b-9b6e-e063-6394a90a97b8Acetaminophen and Diphenhydramine citrateInvaTech Pharma Solutions LLC | Elysium Pharmaceutical Ltd20251002
d9d22e45-1a13-4b45-910d-1183a8e6ed7dHeadache PM (Aspirin Free)Spirit Pharmaceutical LLC20241230
27d83e0f-344a-4527-b86f-a8c7db33a585VALUMEDS ASPIRIN FREE HEADACHE RELIEF PMSPIRIT PHARMACEUTICALS LLC | ELYSIUM PHARMACEUTICALS LIMITED20221121
e5e73f9d-7927-4b7f-be6c-cb8aeda21beeAssured™ Headache PM (Aspirin Free)Spirit Pharmaceutical LLC | Elysium Pharmaceutical Ltd20220113
09b9c5d8-c724-2bb4-e054-00144ff8d46cMidol PMBayer HealthCare LLC. | Bayer HealthCare LLC Consumer Care20211230
a24acde9-cfe3-464f-a9e8-bcbe8f48640dBest Choice 44-373-DelistedValu Merchandisers Company | LNK International, Inc.20171127
b6c6f364-ce8b-4672-818b-2571dda1de06CVS 44-373CVS Pharmacy | LNK International, Inc.20170313
f2cc5a39-6eba-4250-b759-8b6b48fbc40cEqualine 44-373SUPERVALU INC. | LNK International, Inc.20170313
a814ba4a-fbd0-4623-896e-251f55cb9fa2Assured 44-373-DelistedGREENBRIER INTERNATIONAL, INC. | LNK International, Inc.20170302
5ddc7bfa-3655-4233-a227-787a6c1ed90fRite Aid 44-373-DelistedRite Aid Corporation | LNK International, Inc.20170301
b9494fab-a45c-496a-989e-b0cd8d1403ffExchange Select 44-373-DelistedARMY AND AIR FORCE EXCHANGE SERVICE | LNK International, Inc.20170301
0192e93c-e219-4af6-994e-d60918b4f79cNational Council for Prescription Drug Programs20120724
80b59d40-43e9-4287-8697-e026db7ad5caNational Council for Prescription Drug Programs20120724
d7601289-7d2f-4d22-b0cb-9f2d4d14a7d6National Council for Prescription Drug Programs20120724
758407c8-83ea-452b-97cc-a10ab3f07cebNational Council for Prescription Drug Programs20120724
edce3606-9b50-4552-be11-954fedd251a8National Council for Prescription Drug Programs20120724
222b3c50-3064-41ea-a59c-48cb6ed28ec8National Council for Prescription Drug Programs20120724
fb90cced-6b76-4ea9-a0bb-04dc50284772National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCN02BEAnilidesATC1-4acetaminophen
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine citrate
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine citrate
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine citrate
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine citrate
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine citrate
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine citrate
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine citrate
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine citrate
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine citrate
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine citrate
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine citrate
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine citrate
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine citrate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine citrate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
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 / 38 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4010178
NAMESPrescribable Synonymacetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
NAMESTallman SynonymAPAP 500 MG / diphenhydrAMINE Citrate 38 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File