Pain Relief PM

Product NDC
83324-085
11-digit product format
833240085
Labeler code
83324
Product ID
83324-085_1ac8a196-00fa-a986-e063-6294a90a948f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-29
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
TC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE147-24-0DIPHENHYDRAMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-085-01833240085011 BOTTLE, PLASTIC in 1 CARTON (83324-085-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-29NoNoHistorical
83324-085-50833240085501 BOTTLE, PLASTIC in 1 CARTON (83324-085-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1095-QCH-2024-0613CHAIN DRUG MARKETING ASSOCIATION, INC.2024-06-13HUMAN OTC DRUG LABEL2