Home NDC 50580-488 TYLENOL
Product NDC 50580-488
11-digit product format 505800488
Labeler code 50580
Product ID 50580-488_4eda2608-4d48-1af0-e063-6294a90a2c72
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-16
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
Brand name suffix 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-488-01 TYLENOLExtra Strength 2 in 1 POUCH TABLET, COATED 2 18 50580-488-01 TYLENOLExtra Strength 50 in 1 TRAY TABLET, COATED 50 18 50580-488-02 TYLENOLExtra Strength 2 in 1 POUCH TABLET, COATED 2 18 50580-488-02 TYLENOLExtra Strength 5 in 1 CARTON TABLET, COATED 5 18 50580-488-10 TYLENOLExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 18 50580-488-10 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 18 50580-488-22 TYLENOLExtra Strength 200 in 1 BOTTLE TABLET, COATED 200 18 50580-488-22 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 18 50580-488-24 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 18 50580-488-24 TYLENOLExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 18 50580-488-25 TYLENOLExtra Strength 225 in 1 BOTTLE, PLASTIC TABLET, COATED 225 18 50580-488-25 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 18 50580-488-28 TYLENOLExtra Strength 290 in 1 BOTTLE, PLASTIC TABLET, COATED 290 18 50580-488-50 TYLENOLExtra Strength 2500 in 1 CARTON TABLET, COATED 2500 18 50580-488-50 TYLENOLExtra Strength 2 in 1 POUCH TABLET, COATED 2 18 50580-488-52 TYLENOLExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 18 50580-488-52 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-488 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 17 package rows 20241109_1b164780-ec84-4187-8afa-6f8a0da550fc.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 Units Marketing start Marketing end Sample Exclude flag Status 50580-488-01 50580048801 2 in 1 POUCH Historical 50580-488-02 50580048802 5 POUCH in 1 CARTON (50580-488-02) / 2 TABLET, COATED in 1 POUCH 5 pouch 2026-01-15 No No Current 50580-488-10 50580048810 1 BOTTLE, PLASTIC in 1 CARTON (50580-488-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-01-16 0000-00-00 No No Current 50580-488-22 50580048822 1 BOTTLE in 1 CARTON (50580-488-22) / 200 TABLET, COATED in 1 BOTTLE 1 bottle 2026-06-01 No No Current 50580-488-24 50580048824 1 BOTTLE, PLASTIC in 1 CARTON (50580-488-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-01-16 0000-00-00 No No Current 50580-488-25 50580048825 1 BOTTLE, PLASTIC in 1 CARTON (50580-488-25) / 225 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-01-16 0000-00-00 No No Current 50580-488-28 50580048828 290 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-488-28) 2017-01-16 0000-00-00 No No Current 50580-488-50 50580048850 2500 POUCH in 1 CARTON (50580-488-50) / 2 TABLET, COATED in 1 POUCH 2500 pouch 2026-01-15 No No Current 50580-488-52 50580048852 1 BOTTLE, PLASTIC in 1 CARTON (50580-488-52) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2019-06-17 0000-00-00 No No Current