Home NDC 36800-095 Pain Relief PM
Product NDC 36800-095
11-digit product format 368000095
Labeler code 36800
Product ID 36800-095_3ff37f0e-3a25-dfd8-e063-6394a90ae3ca
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler TopCo Associates LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-11-30
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 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 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 36800-095-03 Pain Relief PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 36800-095-03 Pain Relief PMExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5 36800-095-17 Pain Relief PMExtra Strength 225 in 1 BOTTLE, PLASTIC TABLET, COATED 225 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-095 PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TOPCO ASSOCIATES LLC] 4 Current NDC, Legacy NDC, 3 package rows 20241205_3b672ec7-8658-4b43-a79d-094ac8bc6904.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-095-03 36800009503 1 BOTTLE, PLASTIC in 1 CARTON (36800-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-11-30 0000-00-00 No No Current 36800-095-17 36800009517 225 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-095-17) 2019-03-21 0000-00-00 No No Current