FDA.reportPublic FDA data

Pain Relief PM

Product NDC
36800-771
Requested package NDC
36800-771-02
11-digit product format
368000771
Labeler code
36800
Product ID
36800-771_d0c7c946-2b5b-0e81-e053-2a95a90a5458
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TopCo Associates LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-31
Marketing end
2022-06-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-77136800-771-02DDiscontinued by firm2026-07-31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-771-02368000771021 BOTTLE, PLASTIC in 1 CARTON (36800-771-02) > 40 TABLET, COATED in 1 BOTTLE, PLASTIC2014-03-312022-06-30NoNoCurrent