Pain Reliever PM

Product NDC
50844-556
11-digit product format
508440556
Labeler code
50844
Product ID
50844-556_82f8ff4b-21ec-402e-b4ae-0a25d84e2803
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-17
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct50844-556DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50844-55650844-556-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
Brand name suffix
Extra Strength
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
ff199db8-c7ea-4b6e-ad8b-3ceeca883d92Available 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
50844-556-10Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, COATED19
50844-556-10Pain Reliever PMExtra Strength40 in 1 BOTTLE, PLASTICTABLET, COATED409

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-556PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]8Current NDC, Legacy NDC, 2 package rows20240913_ff199db8-c7ea-4b6e-ad8b-3ceeca883d92.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 39 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULINE AspirinASPIRINULINE9b2b053c-11e7-8169-e053-2995a90ae3362025-09-09WarningsExact identifier
application number: M013
Green Guard Chewable Aspirin 81 mgASPIRINUnifirst First Aid Corporaiton173a53ca-b6ea-2042-e063-6294a90a84372025-09-08WarningsExact identifier
application number: M013
Medique Products Chewable Low Dose AspirinASPIRINUnifirst First Aid Corporation17009501-674d-c839-e063-6294a90a59fa2025-09-08WarningsExact identifier
application number: M013
Henry Schein AcetaminophenACETAMINOPHENHenry Schein, Inc.a56a5ca1-578c-40cd-90cc-cc4c2dfec8472025-09-08WarningsExact identifier
application number: M013
Henry Schein AcetaminophenACETAMINOPHENHenry Schein, Inc.f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa2025-09-08WarningsExact identifier
application number: M013
Green Guard Maximum Non-AspirinACETAMINOPHENUnifirst First Aid Corporation30f77d4d-839e-4d96-9f24-0254e6a47b812025-09-08WarningsExact identifier
application number: M013
Green Guard Extra Strength Pain ReliefASPIRIN. CAFFEINEUnifirst First Aid Corporatione729319a-6a2c-bfe6-e053-2a95a90a46202025-09-08WarningsExact identifier
application number: M013
Medique APAPACETAMINOPHENUnifirst First Aid Corporation04805d9c-d959-4870-a185-48b58a8808802025-09-08WarningsExact identifier
application number: M013
Green Guard Maximum Strength Non-AspirinACETAMINOPHENUnifirst First Aid Corporationf77c9554-d1c2-1682-e053-6294a90ac5722025-09-08WarningsExact identifier
application number: M013
Medique Back Pain ReliefMAGNESIUM SALICYLATE TETRAHYDRATEUnifirst First Aid Corporatione5563a0a-776a-83d4-e053-2a95a90a95002025-09-08WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENUnifirst First Aid Corporation56822785-d5fb-4869-971e-5de637c2eda82025-09-08WarningsExact identifier
application number: M013
Medique Medi-Seltzer Pain ReliefASPIFINUnifirst First Aid Corporation3d593dee-b932-b611-e063-6294a90ad3b72025-09-08WarningsExact identifier
application number: M013
Medique Extra Strength APAPACETAMINOPHENUnifirst First Aid Corporationf77f8ef5-4aa8-fa80-e053-6394a90a70c22025-09-08WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINEUnifirst First Aid Corporationc2d7af6b-f477-2462-e053-2995a90aff0f2025-09-08WarningsExact identifier
application number: M013
Medique Extra Strength ApapACETAMINOPHENUnifirst First Aid Corporation14bcbaf9-76b6-f8ba-e063-6294a90a91f62025-09-08WarningsExact identifier
application number: M013
Crane Safety XS Non-AspirinACETAMINOPHEN 500 MGCrane Safety LLC9626b3b2-c8ba-5a58-e053-2995a90a35c82025-09-08WarningsExact identifier
application number: M013
Thompson AspirinASPIRINThompson9623d9c6-f241-bf4a-e053-2a95a90a4eb52025-09-08WarningsExact identifier
application number: M013
Thompson XS Pain AcheASPIRIN, CAFFEINEThompson Safetye87c2874-2a95-6839-e053-2a95a90ad14b2025-09-08WarningsExact identifier
application number: M013
Medique at Home APAPACETAMINOPHENUnifirst First Aid Corporationb5582e23-5079-1f2b-e053-2a95a90ad8002025-09-08WarningsExact identifier
application number: M013
Thompson Extra Strength Non-AspirinACETAMINOPHENThompsonf837c31f-24e5-a8df-e053-6394a90a0b362025-09-08WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNff199db8-c7ea-4b6e-ad8b-3ceeca883d929
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDff199db8-c7ea-4b6e-ad8b-3ceeca883d929
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYff199db8-c7ea-4b6e-ad8b-3ceeca883d929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-556-10508440556101 BOTTLE, PLASTIC in 1 CARTON (50844-556-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent