Home NDC 85828-095 Acetaminophen PM
Product NDC 85828-095
11-digit product format 858280095
Labeler code 85828
Product ID 85828-095_5256c6cd-f079-0186-e063-6394a90ac2f6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Grocery Outlet, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-18
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 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 84 · 1,678 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen PM
Listing expiration 2027-12-31 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 85828-095-03 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 3 85828-095-03 Acetaminophen PM 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85828-095-03 85828009503 1 BOTTLE, PLASTIC in 1 CARTON (85828-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2026-02-18 No No Current