Home NDC 53209-1002 Tylenol PM
Product NDC 53209-1002
11-digit product format 532091002
Labeler code 53209
Product ID 53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen and diphenhydramine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Morning Star OTC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-19
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 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 Tylenol 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup 1092378 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 53209-1002-1 Tylenol PMExtra Strength 2 in 1 BLISTER PACK TABLET, FILM COATED 2 1 53209-1002-2 Tylenol PMExtra Strength 25 in 1 POUCH TABLET, FILM COATED 25 1
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 49 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53209-1002-1 53209100201 2 in 1 BLISTER PACK Historical 53209-1002-2 53209100202 25 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1) 25 blister pack 2025-06-19 No No Current