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 46 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 Warnings Exact identifier application number: M013 CounterAct Pain ACETAMINOPHEN Melaleuca, Inc. 7faf76b4-7f25-377d-e053-2a91aa0a19d4 2025-03-20 Boxed warning, Warnings Exact identifier application number: M013 Mejoral ACETAMINOPHEN, CAFFEINE OPMX LLC 0bccf571-fcb9-2dd5-e063-6294a90a5f16 2025-03-19 Warnings Exact identifier application number: M013 ARTRIFIN 24 CAPLETS ACETAMINOPHEN, ASPIRIN, CAFFEINE OPMX LLC e7f15c2b-a730-b54f-e053-2a95a90a3b3e 2025-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL TARGET Corporation 1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1 2025-03-17 Warnings Exact identifier application number: M013 Signature Select Effervescent Pain Relief ASPIRIN Safeway Inc. 304fca65-2867-c963-e063-6394a90a183f 2025-03-14 Warnings Exact identifier application number: M013 GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 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