FDA.reportPublic FDA data

pain relief PM

Product NDC
41250-195
Requested package NDC
41250-195-02
11-digit product format
412500195
Labeler code
41250
Product ID
41250-195_91d2d116-f61b-e3c1-e053-2995a90af20f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-05-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage41250-19541250-195-02DDiscontinued 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
41250-195-02pain relief PM1 in 1 CARTONTABLET, COATED13
41250-195-02pain relief PM50 in 1 BOTTLE, PLASTICTABLET, COATED503
41250-195-03pain relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1003
41250-195-03pain relief PM1 in 1 CARTONTABLET, COATED13
41250-195-09pain relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1003
41250-195-09pain relief PM2 in 1 CARTONTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-195PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [MEIJER]3Legacy NDC, 6 package rows20241013_8504a0ea-b020-58ba-e053-2a91aa0a81a8.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMeijer8504a0ea-b020-58ba-e053-2a91aa0a81a82024-10-11WarningsExact identifier
ndc (package): 41250-195-02
ndc (product): 41250-195
ndc11 (package): 41250019502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8504a0ea-b020-58ba-e053-2a91aa0a81a83
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8504a0ea-b020-58ba-e053-2a91aa0a81a83
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8504a0ea-b020-58ba-e053-2a91aa0a81a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-195-02412500195021 BOTTLE, PLASTIC in 1 CARTON (41250-195-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC2017-05-010000-00-00NoNoCurrent