FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
50594-863
Requested package NDC
50594-863-10
11-digit product format
505940863
Labeler code
50594
Product ID
50594-863_72821cc3-fc08-4d0e-9380-7c1fad20be9a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Big Lots
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-08-20
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-86350594-863-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
50594-863-10Pain Reliever PMExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1006
50594-863-10Pain Reliever PMExtra Strength1 in 1 BOXTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-863PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [BIG LOTS]5Legacy NDC, 2 package rows20240224_fe1feee5-39da-4773-a98f-f161a8c02d1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNfe1feee5-39da-4773-a98f-f161a8c02d1c6
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDfe1feee5-39da-4773-a98f-f161a8c02d1c6
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYfe1feee5-39da-4773-a98f-f161a8c02d1c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50594-863-10505940863101 BOTTLE, PLASTIC in 1 BOX (50594-863-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2021-08-200000-00-00NoNoCurrent