Home NDC 36800-466 Pain Reliever PM
Product NDC 36800-466
11-digit product format 368000466
Labeler code 36800
Product ID 36800-466_8f866a48-29e1-489c-9798-e5b9c1615243
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-05
Marketing end 2027-12-28
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
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 Reliever PM
Brand name suffix Extra Strength 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 36800-466-10 Pain Reliever PMExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 8 36800-466-10 Pain Reliever PMExtra Strength 1 in 1 BOX TABLET, COATED 1 8 36800-466-50 Pain Reliever PMExtra Strength 1 in 1 BOX TABLET, COATED 1 8 36800-466-50 Pain Reliever PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-466 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)] 8 Current NDC, Legacy NDC, 4 package rows 20250228_923b443d-73cc-4c52-92e4-a075786b1ae3.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 13 of 79 · 1,579 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 36800-466-10 36800046610 1 BOTTLE, PLASTIC in 1 BOX (36800-466-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-11-05 2027-12-28 No No Current 36800-466-50 36800046650 1 BOTTLE, PLASTIC in 1 BOX (36800-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-11-05 2027-12-28 No No Current