Home NDC 36800-556 Pain Relief PM
Product NDC 36800-556
11-digit product format 368000556
Labeler code 36800
Product ID 36800-556_ded0a100-68b0-425e-8e0a-5fd6b7c4239f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Topco Associates, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-03
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 Additional Listing Data#
Finished product Yes
Brand name base Pain Relief 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 36800-556-09 Pain Relief PM 20 in 1 BOTTLE, PLASTIC TABLET, COATED 20 11 36800-556-09 Pain Relief PM 1 in 1 CARTON TABLET, COATED 1 11 36800-556-10 Pain Relief PM 1 in 1 CARTON TABLET, COATED 1 11 36800-556-10 Pain Relief PM 40 in 1 BOTTLE, PLASTIC TABLET, COATED 40 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-556 PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [TOPCO ASSOCIATES, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20250316_eaa98783-5800-4ae9-832f-f4a1fd1790fd.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 84 · 1,678 matching rows.
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 36800-556-09 36800055609 1 BOTTLE, PLASTIC in 1 CARTON (36800-556-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 2020-01-03 0000-00-00 No No Current 36800-556-10 36800055610 1 BOTTLE, PLASTIC in 1 CARTON (36800-556-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC 2020-01-03 0000-00-00 No No Current