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 18 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Enteric Coated ASPIRIN 81 MG Grocery Outlet 79c64e27-87aa-4081-8cbf-343768b00b90 2026-03-19 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE ASPIRIN MAJOR PHARMACEUTICALS 7c24aff7-2b96-27ac-e053-2991aa0a5714 2026-03-19 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack ea417ddb-54b3-49e2-bec1-8fe450d9990c 2026-03-19 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN HyVee Inc 3b08738e-cde2-4843-b609-8f12582c6d08 2026-03-18 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE Salado Sales, Inc. 0666f082-84f3-4041-a322-311188a15670 2026-03-18 Warnings Exact identifier application number: M013 AMAZON BASICS ACETAMINOPHEN ACETAMINOPHEN Amazon.com Services LLC 3c2914a4-913e-7e50-e063-6294a90aff3a 2026-03-18 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack c6cec390-004e-45f6-9388-c662a979f37d 2026-03-17 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Chain Drug Marketing Association, Inc. b32ada58-a098-47d2-9ed2-4d5918657709 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL H E B 21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Topco Associates, LLC eaa98783-5800-4ae9-832f-f4a1fd1790fd 2026-03-16 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Walgreen Company 413b3b95-2867-4534-8290-54f477cccf1e 2026-03-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Grocery Outlet, Inc. 4454d02a-ba49-6c8c-e063-6294a90a4709 2026-03-12 Warnings Exact identifier application number: M013 Aspirin Enteric Coated ASPIRIN CVS Pharmacy c55304be-bfc0-46a8-a37e-2e6ba9098394 2026-03-12 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Amerisource Bergen c280ac64-920c-4d03-9190-03e0196ed5ef 2026-03-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED d79828d8-9279-4ae9-8872-aeca641be5d9 2026-03-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Preferred Pharmaceuticals Inc. 1b5b8bb1-c45d-48f0-b275-9ce1f769fed4 2026-03-09 Warnings Exact identifier application number: M013 foster and thrive childrens pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC e495a27e-eb64-4c42-8942-43bab9918172 2026-03-07 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL CVS PHARMACY 67a190c3-7de0-4f57-be94-d6b8285e1220 2026-03-06 Warnings Exact identifier application number: M013 Back and Body Pain Relief ASPIRIN, CAFFEINE WinCo Foods, LLC cf5c15e9-c45d-4bd6-a887-fd74de5f81b9 2026-03-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Topco Associates, LLC 87af092c-99e6-475d-81af-b9fd8fc337d7 2026-03-06 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