FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
59726-032
11-digit product format
597260032
Labeler code
59726
Product ID
59726-032_0c012085-b9e1-4b90-8c4a-421e2a4e67c6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Diphenhydramine HCI
Dosage form
TABLET, COATED
Route
ORAL
Labeler
P & L Development, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59726-032DDiscontinued by firm2026-10-12
excluded packagepackage59726-03259726-032-50DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-032-502023-03-02C16284748780-1f386c64a-01d7-0266-e053-dadaa90a7c1aDRUG FACTS
59726-032-502023-01-30C16284748780-1f386c64a-01d7-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-032PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN DIPHENHYDRAMINE HCI) TABLET, COATED [P & L DEVELOPMENT, LLC]3Legacy NDC20230303_9ec9e54c-0616-415c-9ecd-ebfa04acebd4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-032-5059726003250500 TABLET, COATED in 1 BOTTLE, PLASTIC (59726-032-50) 2017-12-310000-00-00NoNoCurrent