Home NDC 50580-457 TYLENOL Extra Strength
Product NDC 50580-457
11-digit product format 505800457
Labeler code 50580
Product ID 50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-10
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 50580-457-10 TYLENOL Extra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 9 50580-457-10 TYLENOL Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 9 50580-457-11 TYLENOL Extra Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9 50580-457-11 TYLENOL Extra Strength 10 in 1 CARTON TABLET, FILM COATED 10 9 50580-457-70 TYLENOL Extra Strength 700 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 700 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-457 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250221_c830320e-72ba-48ff-a4cd-250ac5650bf0.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 54 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief ACETAMINOPHEN AAA Pharmaceutical, Inc. a891896d-c9fa-4448-915a-e6b531157d22 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN SAFEWAY d2d15e06-e9eb-3d2b-e053-2995a90a1cec 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN TopCo Associates LLC c2d33352-431c-4683-a4fa-a54437e7b8d2 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb 2024-12-02 Warnings Exact identifier application number: M013 Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc c4473ee6-4e01-1ec2-e053-2995a90ac513 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Proficient Rx LP 9c186289-e309-45e8-8934-1d0eae0375c2 2024-12-01 Warnings Exact identifier application number: M013 Childrens Chewable Acetaminophen ACETAMINOPHEN GERI-CARE PHARMACEUTICAL CORP 22f63d62-c941-5b8f-e063-6394a90aeecd 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Geri-Care Pharmaceutical Corp 7a7b6318-b7d6-31b1-e053-2991aa0abf25 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL INGLES MARKETS, INC. 27fd288e-c07a-617f-e063-6394a90a17a4 2024-11-28 Warnings Exact identifier application number: M013 BAYER Aspirin Original, TRAVEL BASIX ASPIRIN Lil' Drug Store Products, Inc. 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 2024-11-27 Warnings Exact identifier application number: M013 EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE Jones Healthcare Group - Packaging Services, Inc c4168e4d-3dfc-4e51-a32e-14704cb59c66 2024-11-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief ACETAMINOPHEN, LIDOCAINE, MENTHOL Kenvue Brands LLC 2611e984-0dd5-bda1-e063-6394a90a559a 2024-11-26 Warnings Exact identifier application number: M013 First Aid Only Extra-Strength Non-Aspirin ACETAMINOPHEN Acme United Corporation 6891d57a-10a6-53de-e053-2a91aa0ac7c2 2024-11-26 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN MARC GLASSMAN, INC. c8314910-71ff-5a55-e053-2995a90aafc7 2024-11-26 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Marc Glassman, Inc. 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 2024-11-26 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Safeway 96359eb6-62bc-4b13-960c-050af99a8c02 2024-11-26 Warnings Exact identifier application number: M013 ASPIRIN Low Dose ASPIRIN Marc Glassman, Inc. 3d519af3-9398-4439-8253-1e5d4612b8e3 2024-11-26 Warnings Exact identifier application number: M013 ACETAMINOPHEN (RED) ACETAMINOPHEN Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 06eabf4b-f8c0-439a-acf1-aa6e3075c717 2024-11-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN (RED) ACETAMINOPHEN Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd a352f588-4a70-42b2-8f9c-a73a0629517d 2024-11-25 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 Marketing end Sample Exclude flag Status 50580-457-10 50580045710 1 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2020-07-10 0000-00-00 No No Current 50580-457-11 50580045711 10 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2020-07-17 0000-00-00 No No Current 50580-457-70 50580045770 700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70) 2020-07-17 0000-00-00 No No Current