FDA.reportPublic FDA data

acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet

RxCUI
1593110
RxNorm name
acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet
Display name
Acetaminophen/Aspirin/diphenhydrAMINE (Oral Pill)
Full name
acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet
Term type
SCD
Status
Active
Strength
250-250-38 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-15 14:49:29

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122014
Active start
122014
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
aspirin250 MG / 1 EACHaspirinaspirin
acetaminophen250 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
aspirin1191
acetaminophen161
diphenhydramine3498

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI15931101CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
51316-674-1251316-674PM Headache Acetaminophen, Aspirin, Diphenhydramine citrateCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDM013
59779-894-1259779-894Pain Relief PM Acetaminophen, Aspirin, Diphenhydramine citrateCVS PharmacyM013

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01351316-674PM Headache Acetaminophen, Aspirin, Diphenhydramine citrateOTC MONOGRAPH DRUGCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 8 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00363989412rxnav_ndcsyes
46122045671rxnav_ndcsyes
51316067412rxnav_ndcsyes
59779089412rxnav_ndcsyes
11917018359rxnav_historical
49467023010rxnav_historical
55910067415rxnav_historical
63941067415rxnav_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
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
rxcui: 1593110
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
ndc (package): 59779-894-12
ndc (product): 59779-894
ndc11 (package): 59779089412
rxcui: 1593110
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
rxcui: 1593110
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
rxcui: 1593110

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 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ddd78b28-6e10-4708-bed1-8aea087b3d82acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]313CVS 44-674-Delisted20260211
b3812d27-40af-40d7-864a-dfa4ae34cb9eacetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]39Drug Facts20240314
444fa225-c204-45d1-b3b3-aa5650ee5d07acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]36Drug Facts20260223
f03f43af-4db8-4b61-8371-6b6d8ce71712acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]36MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), Caplets20230209
978a9d27-6d41-42cb-a193-11314923d2acacetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]35Drug Facts20240314
72e7ff12-c7bd-447d-8da6-fdfffc55f274acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]32CVS 44-674 PM Headache20250911
7af271d5-94e9-4a08-a9f2-270854089de7acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet [PSN] · acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [SCD] · APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet [SY]32HEADACHE RELIEF PM20171213

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
72e7ff12-c7bd-447d-8da6-fdfffc55f274CVS 44-674 PM HeadacheCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.20260911
ddd78b28-6e10-4708-bed1-8aea087b3d82CVS 44-674-DelistedCVS Pharmacy | LNK International, Inc.20260211
72e7ff12-c7bd-447d-8da6-fdfffc55f274CVS 44-674 PM HeadacheCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.20250911
f56c438a-0593-421f-8a7c-903d1874c8eaGood Neighbor Pharmacy 44-674-DelistedAmerisource Bergen | LNK International, Inc.20250902
2547f2ca-ea36-4ded-8a51-fb83b293d336Best Choice 44-674 DelistedValu Merchandisers Company | LNK International, Inc.20240726
f03f43af-4db8-4b61-8371-6b6d8ce71712MYGRIN ® Nighttime (Acetaminophen, Aspirin (NSAID), and Diphenhydramine Citrate), CapletsSunascen Therapeutics LLC20230209
a2fe05af-7cc2-4981-9557-c5fd589ab2a4Dollar General 44-674DOLGENCORP, LLC | LNK International, Inc.20210724
7af271d5-94e9-4a08-a9f2-270854089de7HEADACHE RELIEF PMWalgreens | Spirit Pharmaceuticals LLC | MOLECULES DRUGS & RESEARCH LABORATORY PVT. LTD.20171213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCN02BEAnilidesATC1-4acetaminophen
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
ATCA01ADOther agents for local oral treatmentATC1-4aspirin
ATCB01ACPlatelet aggregation inhibitors excl. heparinATC1-4aspirin
ATCN02BASalicylic acid and derivativesATC1-4aspirin
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000175722Nonsteroidal Anti-inflammatory DrugEPChas_epcaspirin
FDASPLN0000175578Platelet Aggregation InhibitorEPChas_epcaspirin
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD001241AspirinCHEMhas_ingredientaspirin
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine citrate
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine citrate
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001172Arthritis, RheumatoidDISEASEmay_treataspirin
MEDRTD001778Blood Coagulation DisordersDISEASEci_withaspirin
MEDRTD001791Blood Platelet DisordersDISEASEci_withaspirin
MEDRTD002544Cerebral InfarctionDISEASEmay_preventaspirin
MEDRTD002644ChickenpoxDISEASEci_withaspirin
MEDRTD002675Child, PreschoolDISEASEci_withaspirin
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withaspirin
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine citrate
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treataspirin
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006073GoutDISEASEmay_treataspirin
MEDRTD006396HematemesisDISEASEci_withaspirin
MEDRTD006474Hemorrhagic DisordersDISEASEci_withaspirin
MEDRTD007223InfantDISEASEci_withaspirin
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine citrate
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine citrate
MEDRTD007249InflammationDISEASEmay_treataspirin
MEDRTD002546Ischemic Attack, TransientDISEASEmay_preventaspirin
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine citrate
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD008551MelenaDISEASEci_withaspirin
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine citrate
MEDRTD009203Myocardial InfarctionDISEASEmay_preventaspirin
MEDRTD009298Nasal PolypsDISEASEci_withaspirin
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine citrate
MEDRTD010003OsteoarthritisDISEASEmay_treataspirin
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_preventaspirin
MEDRTD010146PainDISEASEmay_treataspirin
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD011225Pre-EclampsiaDISEASEmay_preventaspirin
MEDRTD011263Pregnancy Trimester, ThirdDISEASEci_withaspirin
MEDRTD012213Rheumatic FeverDISEASEmay_treataspirin
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine citrate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine citrate
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine citrate
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine citrate
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine citrate
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTN0000000160Cyclooxygenase InhibitorsMOAhas_moaaspirin
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine citrate
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008831Decreased Platelet Activating Factor ProductionPEhas_peaspirin
MEDRTN0000008832Decreased Platelet AggregationPEhas_peaspirin
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peaspirin
MEDRTN0000009006Decreased Thromboxane ProductionPEhas_peaspirin
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkaspirin
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkaspirin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH250 MG / 250 MG / 38 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymacetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
NAMESTallman Synonymacetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
NAMESTallman SynonymAPAP 250 MG / ASA 250 MG / diphenhydrAMINE Citrate 38 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary