FDA.reportPublic FDA data

acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule

RxCUI
1117245
RxNorm name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule
Display name
Acetaminophen/diphenhydrAMINE (Oral Pill)
Full name
acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule
Term type
SCD
Status
Active
Strength
500-25 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-25 06:54:51

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092011
Active start
092011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID4b1ad683-9b5a-622f-e063-6294a90a475cCODES
SPL_SET_ID4b829c72-349a-e52c-e063-6394a90aca8dCODES
SPL_SET_ID5486d426-4709-0bed-e054-00144ff8d46cCODES
SPL_SET_IDcf370a59-42d5-42fe-882f-09885c55f570CODES
RxCUI1117245CODES
MMSL_CODECD27591CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
55315-988-2455315-988Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HClFREDS, INCpart343
84126-375-0184126-375Vicks PainQuil PM Acetaminophen, Diphenhydramine HClThe Procter & Gamble Manufacturing CompanyM013

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
part34355315-988Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HClOTC MONOGRAPH NOT FINALFREDS, INC
M01384126-375Vicks PainQuil PM Acetaminophen, Diphenhydramine HClOTC MONOGRAPH DRUGThe Procter & Gamble Manufacturing Company

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
55315098824rxnav_ndcsyes
84126037501rxnav_ndcsyes
00113082927rxnav_historical
00113082949rxnav_historical
00113082960rxnav_historical
00363037115rxnav_historical
11673055631rxnav_historical
11822055601rxnav_historical
11822055603rxnav_historical
11822055609rxnav_historical
21130055631rxnav_historical
30142004427rxnav_historical
30142004460rxnav_historical
30142082927rxnav_historical
30142082960rxnav_historical
30142082978rxnav_historical
36800082927rxnav_historical
36800082949rxnav_historical
36800082960rxnav_historical
37808082960rxnav_historical_indirect
41250082927rxnav_historical
41250082949rxnav_historical
41520082927rxnav_historical
41520082960rxnav_historical
42507082927rxnav_historical
42507082949rxnav_historical
42507082960rxnav_historical
46122002658rxnav_historical
49035055609rxnav_historical
49035055631rxnav_historical
49738065509rxnav_historical
49738065531rxnav_historical
49738082927rxnav_historical
49738082960rxnav_historical
55301055609rxnav_historical
55312082949rxnav_historical
55315055610rxnav_historical
55315055710rxnav_historical
55315099010rxnav_historical
55319023703rxnav_historical
55319023712rxnav_historical
55319055609rxnav_historical
55319055612rxnav_historical
55319055631rxnav_historical
55910055609rxnav_historical
55910065531rxnav_historical
59726036050rxnav_historical
59779055609rxnav_historical
59779055610rxnav_historical
59779055631rxnav_historical
59779055676rxnav_historical
63941055610rxnav_historical
63981055654rxnav_historical
70253055610rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
cf370a59-42d5-42fe-882f-09885c55f570APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSY9Drug Facts20240214
cf370a59-42d5-42fe-882f-09885c55f570acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN9Drug Facts20240214
cf370a59-42d5-42fe-882f-09885c55f570acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9Drug Facts20240214
4b1ad683-9b5a-622f-e063-6294a90a475cacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN2PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid20260220
4b1ad683-9b5a-622f-e063-6294a90a475cAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSY2PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid20260220
4b1ad683-9b5a-622f-e063-6294a90a475cacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid20260220
4b829c72-349a-e52c-e063-6394a90aca8dacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1PainQuil Liquicaps Pain Reliever / PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid Convenience Pack20260223
4b829c72-349a-e52c-e063-6394a90aca8dacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN1PainQuil Liquicaps Pain Reliever / PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid Convenience Pack20260223
4b829c72-349a-e52c-e063-6394a90aca8dAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSY1PainQuil Liquicaps Pain Reliever / PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid Convenience Pack20260223
5498dc41-9e2a-3dad-e054-00144ff8d46cacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170718
5498dc41-9e2a-3dad-e054-00144ff8d46cAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSY1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170718
5498dc41-9e2a-3dad-e054-00144ff8d46cacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170718
5486d426-4709-0bed-e054-00144ff8d46cacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral CapsulePSN1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170717
5486d426-4709-0bed-e054-00144ff8d46cAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSY1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170717
5486d426-4709-0bed-e054-00144ff8d46cacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170717

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
8e65478b-7a7b-416c-b8e3-23dad79f8cc1Dollar General 44-556DOLGENCORP, LLC | LNK International, Inc.20260416
4b829c72-349a-e52c-e063-6394a90aca8dPainQuil Liquicaps Pain Reliever / PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid Convenience PackThe Procter & Gamble Manufacturing Company20260223
4b1ad683-9b5a-622f-e063-6294a90a475cPainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-AidThe Procter & Gamble Manufacturing Company20260220
f77f0120-4042-4b11-ba9c-cd35e1cd0beeRite Aid 44-556Rite Aid Corporation | LNK International, Inc.20260105
5498dc41-9e2a-3dad-e054-00144ff8d46cEXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg eachFREDS, INC20170718
5486d426-4709-0bed-e054-00144ff8d46cEXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg eachFREDS, INC20170717

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 hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
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 / 25 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESMMSL_CODECD27591
CODESRxCUI1117245
CODESSPL_SET_ID4b1ad683-9b5a-622f-e063-6294a90a475c
CODESSPL_SET_ID4b829c72-349a-e52c-e063-6394a90aca8d
CODESSPL_SET_ID5486d426-4709-0bed-e054-00144ff8d46c
CODESSPL_SET_IDcf370a59-42d5-42fe-882f-09885c55f570
CODESVUID4035420
NAMESPrescribable Synonymacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule
NAMESRxNorm SynonymAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule
NAMESTallman Synonymacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral Capsule
NAMESTallman SynonymAPAP 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral Capsule
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK