Home NDC 83324-085-01 Pain Relief PM
Product NDC 83324-085
Requested package NDC 83324-085-01
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pain Relief PM
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-085-01 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 2 83324-085-01 Pain Relief PMExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 2 83324-085-50 Pain Relief PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 2 83324-085-50 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-085 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 2 Current NDC, 4 package rows 20240615_3ce5bbf2-d449-464e-abeb-5c26866d1ab5.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 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-085-01 83324008501 1 BOTTLE, PLASTIC in 1 CARTON (83324-085-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-29 No No Current