Pain Reliever PM

Product NDC
50844-256
11-digit product format
508440256
Labeler code
50844
Product ID
50844-256_0b04ddec-7b7f-413c-a74e-68ca4635a6b8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Reliever PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec902e52-0f48-4a61-b67d-17e1c1461619Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-256-08Pain Reliever PM1 in 1 CARTONTABLET, FILM COATED18
50844-256-08Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET, FILM COATED248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-256PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 2 package rows20241115_ec902e52-0f48-4a61-b67d-17e1c1461619.zip

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 13 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPEACETAMINOPHENDeMoulas Market Basket0ff5c86e-d84b-42ad-b749-636ab2e3734e2026-05-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.f7e6e984-f0c3-ed40-e053-6294a90a89f72026-05-08WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
application number: M013
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack816b65d7-e53f-44c4-a418-074279d4b2af2026-05-08WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPinnacle RX LLC513cf0e1-6874-9402-e063-6294a90aedc62026-05-07WarningsExact identifier
application number: M013
Infants Pain and Fever Cherry FlavorACETAMINOPHENGenexa Inc.19215ea7-d55f-8d81-e063-6294a90a49242026-05-07WarningsExact identifier
application number: M013
up and up acetaminophen infantsACETAMINOPHENTarget Corporationc1dd8330-fb6b-4d1f-9484-c199dc69214d2026-05-07WarningsExact identifier
application number: M013
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNec902e52-0f48-4a61-b67d-17e1c14616198
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDec902e52-0f48-4a61-b67d-17e1c14616198
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYec902e52-0f48-4a61-b67d-17e1c14616198

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-256-08508440256081 BOTTLE, PLASTIC in 1 CARTON (50844-256-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-07-300000-00-00NoNoCurrent