Home NDC 53209-1001 TYLENOL Extra Strength
Product NDC 53209-1001
11-digit product format 532091001
Labeler code 53209
Product ID 53209-1001_37e8d749-91bb-a5bc-e063-6394a90ac8a8
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Morning Star OTC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1984-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53209-1001-1 TYLENOL Extra Strength 2 in 1 BLISTER PACK TABLET, FILM COATED 2 1 53209-1001-2 TYLENOL Extra 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 65 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diphenhydramine HCL DIPHENHYDRAMINE HCL NuCare Pharmaceuticals, Inc. 5411544e-3c2d-4e42-e054-00144ff8d46c 2024-07-10 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L. Perrigo Company b97c51ad-4953-4491-9ceb-395550eb5296 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 065e6f1b-f68c-491a-a157-84961a07e3d9 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 3b7b6725-2996-44d3-89a3-032384e7e2ce 2024-07-10 Warnings Exact identifier application number: M013 equate pain and fever infants ACETAMINOPHEN Wal-Mart Stores Inc 8a152c8d-8ae0-4201-8bb9-7b22c3577415 2024-07-10 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WinCo Foods, LLC 3c57498c-86b0-4ba3-881e-c742a2e8ece5 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Bryant Ranch Prepack 61ecf3c9-42fa-4ae4-bd3b-694090477b9a 2024-07-09 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC fa0ce51f-441d-4409-8617-b3402b00f187 2024-07-08 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Exact identifier application number: M013 Best Choice Effervescent Pain Reliever 36 ASPIRIN VALU MERCHANDISERS COMPANY 12f1278e-88b6-0460-e063-6394a90abf0e 2024-07-03 Warnings Exact identifier application number: M013 Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALMART INC. 16d5786c-2346-f970-e063-6394a90a0a8c 2024-07-03 Warnings Exact identifier application number: M013 topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC a1145ac3-3e55-4bd5-a53e-6cf869add9a1 2024-07-02 Warnings Exact identifier application number: M013 Drug Mart Effervescent Pain Relief ASPIRIN Discount Drug Mart Inc 1c35f394-a221-6531-e063-6394a90acb8a 2024-07-01 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53209-1001-1 53209100101 2 in 1 BLISTER PACK Historical 53209-1001-2 53209100102 25 BLISTER PACK in 1 POUCH (53209-1001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1001-1) 25 blister pack 2025-06-19 No No Current