FDA.reportPublic FDA data

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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6fee238-0b6f-cb84-e053-2995a90a361b2024-12-05WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEL.N.K. International, Inc.379ef03c-3b6a-40c3-b736-99f0537d26c82024-12-05WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENMarc Glassman, Inc.43bf297f-2832-424f-a013-4bfa1d6c03e62024-12-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.5a68ab98-720c-479a-a60a-4e594add6c092024-12-04WarningsExact identifier
application number: M013
HEB Effervescent Pain ReliefASPIRINH. E. BUTT GROCERY COMPANY03876c71-60ec-3280-e063-6294a90a62dc2024-12-03WarningsExact identifier
application number: M013
Migrafein FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028875c9-4129-ce2c-e063-6294a90a26cc2024-12-03WarningsExact identifier
application number: M013
Neo-Lubrina FuerteACETAMINOPHEN, CAFFEINEOPMX LLC0288a327-fd4b-1991-e063-6294a90ace502024-12-03WarningsExact identifier
application number: M013
CAFIZETAMOL FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028771d3-a514-f7a5-e063-6394a90ac4f32024-12-03WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC048c4b03-1cf4-b724-e063-6294a90a1cad2024-12-03WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCecd6df7e-e7e2-446b-85ef-25971281fe312024-12-03WarningsExact identifier
application number: M013
Market Basket Effervescent Pain ReliefASPIRINDEMOULAS SUPER MARKETS, INC.08133bf0-3c8f-e4d0-e063-6294a90af79a2024-12-03WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWinCo Foods, LLC4359da13-e851-440b-91b9-6b544bff20d22024-12-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWinCo Foods, LLC5b3e8a78-5357-42ad-811e-b2578b25dc7b2024-12-03WarningsExact identifier
application number: M013
Low Strength Chewable AspirinASPIRINGeri-Care Pharmaceutical Corpcc77b9d1-7874-4ce8-a763-3a0e1c2891de2024-12-03WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association0e3be5f4-bc1b-4b44-a86a-ace89f6ee5922024-12-02WarningsExact identifier
application number: M013
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact 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