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 18 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Enteric CoatedASPIRIN 81 MGGrocery Outlet79c64e27-87aa-4081-8cbf-343768b00b902026-03-19WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRINMAJOR PHARMACEUTICALS7c24aff7-2b96-27ac-e053-2991aa0a57142026-03-19WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENBryant Ranch Prepackea417ddb-54b3-49e2-bec1-8fe450d9990c2026-03-19WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENHyVee Inc3b08738e-cde2-4843-b609-8f12582c6d082026-03-18WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.0666f082-84f3-4041-a322-311188a156702026-03-18WarningsExact identifier
application number: M013
AMAZON BASICS ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC3c2914a4-913e-7e50-e063-6294a90aff3a2026-03-18WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackc6cec390-004e-45f6-9388-c662a979f37d2026-03-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINChain Drug Marketing Association, Inc.b32ada58-a098-47d2-9ed2-4d59186577092026-03-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLH E B21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a2026-03-16WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTopco Associates, LLCeaa98783-5800-4ae9-832f-f4a1fd1790fd2026-03-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWalgreen Company413b3b95-2867-4534-8290-54f477cccf1e2026-03-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGrocery Outlet, Inc.4454d02a-ba49-6c8c-e063-6294a90a47092026-03-12WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCVS Pharmacyc55304be-bfc0-46a8-a37e-2e6ba90983942026-03-12WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAmerisource Bergenc280ac64-920c-4d03-9190-03e0196ed5ef2026-03-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd79828d8-9279-4ae9-8872-aeca641be5d92026-03-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINPreferred Pharmaceuticals Inc.1b5b8bb1-c45d-48f0-b275-9ce1f769fed42026-03-09WarningsExact identifier
application number: M013
foster and thrive childrens pain and feverACETAMINOPHENStrategic Sourcing Services LLCe495a27e-eb64-4c42-8942-43bab99181722026-03-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY67a190c3-7de0-4f57-be94-d6b8285e12202026-03-06WarningsExact identifier
application number: M013
Back and Body Pain ReliefASPIRIN, CAFFEINEWinCo Foods, LLCcf5c15e9-c45d-4bd6-a887-fd74de5f81b92026-03-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTopco Associates, LLC87af092c-99e6-475d-81af-b9fd8fc337d72026-03-06WarningsExact 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