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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Oral Capsule1NAMES
RxNorm Nameacetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule1NAMES
RxNorm SynonymAPAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI11172451CODES
MMSL_CODECD275911CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 54 matching rows.

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEVER PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)cf370a59-42d5-42fe-882f-09885c55f5702026-06-11WarningsExact identifier
rxcui: 1117245
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
ndc11 (package): 55910065531
Vicks PainQuil and Vicks PainQuil PM LIQUICAPS PAIN RELIEVERACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company4b829c72-349a-e52c-e063-6394a90aca8d2026-02-23WarningsExact identifier
ndc (package): 84126-375-01
ndc11 (package): 84126037501
rxcui: 1117245
Vicks PainQuil PM LIQUICAPS PAIN RELIEVER plus NIGHTTIME SLEEP-AIDACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company4b1ad683-9b5a-622f-e063-6294a90a475c2026-02-20WarningsExact identifier
ndc (package): 84126-375-01
ndc (product): 84126-375
ndc11 (package): 84126037501
rxcui: 1117245
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
ndc11 (package): 11822055609
ndc11 (package): 11822055603
ndc11 (package): 11822055601

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
cf370a59-42d5-42fe-882f-09885c55f570acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SCD] · APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SY]39Drug Facts20240214
4b1ad683-9b5a-622f-e063-6294a90a475cacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SCD] · APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SY]32PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid20260220
4b829c72-349a-e52c-e063-6394a90aca8dacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SCD] · APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SY]31PainQuil Liquicaps Pain Reliever / PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid Convenience Pack20260223
5498dc41-9e2a-3dad-e054-00144ff8d46cacetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Capsule [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SCD] · APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SY]31EXTRA 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 Capsule [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SCD] · APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Capsule [SY]31EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each20170717

Recently Linked 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
58894f98-6d11-4e2f-bf50-d2890f5cc70eSignature Care 44-556 DelistedBetter Living Brands, LLC | LNK International, Inc.20230531
5bb27ecf-7daa-48b3-9224-5dbcd4a314e1Best Choice 44-556-DelistedValu Merchandisers Company | LNK International, Inc.20230508
e67bd3b7-03bc-4164-b9c2-4dd679ce6916Kirkland 44-556-Rapid Release DelistedCOSTCO WHOLESALE CORPORATION | LNK International, Inc.20221119
f3aae7a9-e377-4c33-be79-40ffd4de12d2Equate 44-556 - DelistedWal-Mart Stores Inc | LNK International, Inc.20210528
7b44e456-e9da-46ac-a805-0ffc0cab5992Drug FactsFamily Dollar (FAMILY WELLNESS)20201207
77428e30-5987-4ab3-acc9-11e81ab0d1bdFreds 44-556-DelistedFRED'S, INC. | LNK International, Inc.20200612
c3babea3-15be-1475-27d3-a787e1f56518CVS 44-556-delistedCVS Pharmacy | LNK International, Inc.20200303
27dc7753-d058-41fd-852b-6871e6709fd5Family Wellness 44-556-DelistedFamily Dollar Services Inc | LNK International, Inc.20191213
287365ea-cb4c-4b3b-9f4b-0fb128421640Target 44-556-DelistedTarget Corporation | LNK International, Inc.20191014
792483e2-1e42-4ea6-8ee9-af059e6ccf69Smart Sense 44-556-DelistedKmart Corporation | LNK International, Inc.20180726
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
9e52822b-b8f2-4fd3-af6e-87ff99d84e4fNational Council for Prescription Drug Programs20120724
a5b9cfeb-5c26-4c59-acb6-ff57057b7f7dNational Council for Prescription Drug Programs20120724
3c1e9354-99c1-4786-9010-71eec887f3bbNational Council for Prescription Drug Programs20120724
2b4acadc-a76d-4754-9dd4-41a5c46918e0National Council for Prescription Drug Programs20120724
8e028c0e-b94c-4f06-bf76-04110a3b884bExtra Strength Pain Relief PMP and L Development of New York Corporation20120423

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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
CODESVUID4035420
NAMESPrescribable Synonymacetaminophen 500 MG / diphenhydrAMINE HCl 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