Home NDC 50580-937 Tylenol Extra Strength
Product NDC 50580-937
11-digit product format 505800937
Labeler code 50580
Product ID 50580-937_572fcd5f-40f6-eaf1-e063-6294a90a4143
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 2019-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 2027-12-31 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-937-01 Tylenol Extra Strength 10 in 1 VIAL TABLET, FILM COATED 10 15 50580-937-01 Tylenol Extra Strength 12 in 1 PACKAGE TABLET, FILM COATED 12 15 50580-937-02 Tylenol Extra Strength 10 in 1 VIAL TABLET, FILM COATED 10 15 50580-937-02 Tylenol Extra Strength 12 in 1 PACKAGE TABLET, FILM COATED 12 15 50580-937-03 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-04 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-04 Tylenol Extra Strength 3 in 1 CARTON TABLET, FILM COATED 3 15 50580-937-05 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-05 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-06 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-06 Tylenol Extra Strength 24 in 1 BOTTLE TABLET, FILM COATED 24 15 50580-937-07 Tylenol Extra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 15 50580-937-07 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-10 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-10 Tylenol Extra Strength 50 in 1 BOTTLE TABLET, FILM COATED 50 15 50580-937-15 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 50580-937-15 Tylenol Extra Strength 225 in 1 BOTTLE TABLET, FILM COATED 225 15 50580-937-19 Tylenol Extra Strength 325 in 1 BOTTLE TABLET, FILM COATED 325 15 50580-937-20 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-20 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-23 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-23 Tylenol Extra Strength 3 in 1 CARTON TABLET, FILM COATED 3 15 50580-937-25 Tylenol Extra Strength 2500 in 1 CASE TABLET, FILM COATED 2500 15 50580-937-25 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-37 Tylenol Extra Strength 320 in 1 BOTTLE TABLET, FILM COATED 320 15 50580-937-50 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-50 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-51 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 15 50580-937-51 Tylenol Extra Strength 50 in 1 CARTON TABLET, FILM COATED 50 15 50580-937-66 Tylenol Extra Strength 2 in 1 CARTON TABLET, FILM COATED 2 15 50580-937-66 Tylenol Extra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-937 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 13 Current NDC, Legacy NDC, 31 package rows 20250221_103d109d-f520-409c-8da2-eb6b0fbec891.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 2 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MAX relief junior ACETAMINOPHEN Akron Pharma Inc. 0e43b885-3843-4f11-9a53-02a38c228313 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior CHILDREN ACETAMINOPHEN Akron Pharma Inc. d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior Grape CHILDREN ACETAMINOPHEN Akron Pharma Inc. 3c7a7f40-4963-4fd1-942e-93fa08a45830 2026-08-31 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 5a615118-33c9-1520-e063-6394a90a21a6 2026-08-31 Warnings Exact identifier application number: M013 acetaminophen extra strength ACETAMINOPHEN Sam's West Inc dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d 2026-08-28 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN HAWAII REPACK, INC. ac94cce3-9a39-41de-bb8b-10a5e5b8e83b 2026-08-28 Warnings Exact identifier application number: M013 Aspirin ASPIRIN WinCo Foods, LLC a0a19cd1-eb8a-4773-be00-78de90d2a3c3 2026-08-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN FSA STORE INC. 5502ef15-9f40-db56-e063-6394a90a2de4 2026-08-26 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d 2026-08-26 Warnings Exact identifier application number: M013 HyVee Extra Strength Headache Relief CAPLET ACETAMINOPHEN, ASPIRIN, CAFFEINE HyVee Inc 495c75bf-c09a-accd-e063-6294a90a75ec 2026-08-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walgreens 543f93d1-df14-0bd2-e063-6294a90a4413 2026-08-24 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Akron Pharma Inc. ab79fd60-8315-4c63-8045-1b0511ac268f 2026-08-24 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. 4fd048c3-70bc-2ea7-e063-6394a90a55f2 2026-08-22 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 59adabeb-97e8-2de4-e063-6394a90acc47 2026-08-22 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Publix Super Markets Inc a876daa7-ade3-497d-87bb-46d6e4dc185a 2026-08-21 Warnings Exact identifier application number: M013 equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Exact identifier application number: M013 aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 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 50580-937-01 50580093701 12 VIAL in 1 PACKAGE (50580-937-01) / 10 TABLET, FILM COATED in 1 VIAL 12 vial 2019-08-19 0000-00-00 No No Current 50580-937-02 50580093702 12 VIAL in 1 PACKAGE (50580-937-02) / 10 TABLET, FILM COATED in 1 VIAL 12 vial 2019-09-16 0000-00-00 No No Current 50580-937-03 50580093703 2 TABLET, FILM COATED in 1 POUCH (50580-937-03) 2020-07-31 0000-00-00 No No Current 50580-937-04 50580093704 3 POUCH in 1 CARTON (50580-937-04) > 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2020-07-31 0000-00-00 No No Current 50580-937-05 50580093705 50 POUCH in 1 CARTON (50580-937-05) > 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2020-07-31 0000-00-00 No No Current 50580-937-06 50580093706 1 BOTTLE in 1 CARTON (50580-937-06) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-07 50580093707 1 BOTTLE in 1 CARTON (50580-937-07) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-10 50580093710 1 BOTTLE in 1 CARTON (50580-937-10) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-15 50580093715 1 BOTTLE in 1 CARTON (50580-937-15) / 225 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-08-31 0000-00-00 No No Current 50580-937-19 50580093719 325 TABLET, FILM COATED in 1 BOTTLE (50580-937-19) 2020-08-31 0000-00-00 No No Current 50580-937-20 50580093720 50 POUCH in 1 CARTON (50580-937-20) > 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2020-07-31 0000-00-00 No No Current 50580-937-23 50580093723 3 POUCH in 1 CARTON (50580-937-23) / 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2026-01-15 No No Current 50580-937-25 50580093725 2500 POUCH in 1 CASE (50580-937-25) / 2 TABLET, FILM COATED in 1 POUCH 2500 pouch 2025-12-28 No No Current 50580-937-37 50580093737 320 TABLET, FILM COATED in 1 BOTTLE (50580-937-37) 2026-03-31 No No Current 50580-937-50 50580093750 50 POUCH in 1 CARTON (50580-937-50) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2025-12-28 No No Current 50580-937-51 50580093751 50 POUCH in 1 CARTON (50580-937-51) / 2 TABLET, FILM COATED in 1 POUCH 50 pouch 2025-12-28 No No Current 50580-937-66 50580093766 2 BOTTLE in 1 CARTON (50580-937-66) / 100 TABLET, FILM COATED in 1 BOTTLE 2 bottle 2024-05-01 No No Current