Home NDC 69607-8630 Pain Reliever PM
Product NDC 69607-8630
11-digit product format 696078630
Labeler code 69607
Product ID 69607-8630_a93c6c12-674e-425e-9015-e40fe4b059f6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler WR Group, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-28
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 Additional Listing Data#
Finished product Yes
Brand name base Pain Reliever PM
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 69607-8630-1 Pain Reliever PM 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 2 69607-8630-1 Pain Reliever PM 1 in 1 BOX TABLET, COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69607-8630 PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WR GROUP, INC.] 2 Current NDC, 2 package rows 20250331_8281771c-485c-42a9-9a1c-9a7a4298c5b8.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 85 · 1,681 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 69607-8630-1 69607863001 1 BOTTLE, PLASTIC in 1 BOX (69607-8630-1) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2025-02-28 No No Current