Home NDC 50580-937-03 Tylenol Extra Strength
Product NDC 50580-937
Requested package NDC 50580-937-03
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-937-03 50580093703 2 TABLET, FILM COATED in 1 POUCH (50580-937-03) 2020-07-31 0000-00-00 No No Current