Home NDC 70264-028 TYLENOL PM EXTRA STRENGTH
Product NDC 70264-028
11-digit product format 702640028
Labeler code 70264
Product ID 70264-028_43c8c37c-62db-f6e0-e063-6394a90aab46
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler R J General Corporation
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
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 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 70264-028-01 TYLENOL PM EXTRA STRENGTH 2 in 1 POUCH TABLET, FILM COATED 2 4 70264-028-01 TYLENOL PM EXTRA STRENGTH 50 in 1 BOX TABLET, FILM COATED 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70264-028 TYLENOL PM EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [R J GENERAL CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20241030_a40ea0e3-d666-4605-b5e0-beeaf8f586f2.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 60 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 Marketing end Sample Exclude flag Status 70264-028-01 70264002801 50 POUCH in 1 BOX (70264-028-01) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2021-05-01 0000-00-00 No No Current