Home NDC 50580-490-02 TYLENOL Extra Strength
Product NDC 50580-490
Requested package NDC 50580-490-02
11-digit product format 505800490
Labeler code 50580
Product ID 50580-490_4eda2e16-ed91-59d6-e063-6394a90abf72
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 2021-04-30
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 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 50580-490-02 TYLENOL Extra Strength 200 in 1 BOTTLE TABLET, COATED 200 8 50580-490-02 TYLENOL Extra Strength 1 in 1 CARTON TABLET, COATED 1 8 50580-490-10 TYLENOL Extra Strength 1 in 1 CARTON TABLET, COATED 1 8 50580-490-10 TYLENOL Extra Strength 100 in 1 BOTTLE TABLET, COATED 100 8 50580-490-20 TYLENOL Extra Strength 100 in 1 BOTTLE TABLET, COATED 100 8 50580-490-20 TYLENOL Extra Strength 2 in 1 CARTON TABLET, COATED 2 8 50580-490-24 TYLENOL Extra Strength 1 in 1 CARTON TABLET, COATED 1 8 50580-490-24 TYLENOL Extra Strength 24 in 1 BOTTLE TABLET, COATED 24 8 50580-490-25 TYLENOL Extra Strength 225 in 1 BOTTLE TABLET, COATED 225 8 50580-490-25 TYLENOL Extra Strength 1 in 1 CARTON TABLET, COATED 1 8 50580-490-50 TYLENOL Extra Strength 1 in 1 CARTON TABLET, COATED 1 8 50580-490-50 TYLENOL Extra Strength 50 in 1 BOTTLE TABLET, COATED 50 8 50580-490-90 TYLENOL Extra Strength 290 in 1 BOTTLE TABLET, COATED 290 8 50580-490-25 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 225 in 1 BOTTLE TABLET, COATED 225 500 mg 1 50580-490-25 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief 1 in 1 CARTON TABLET, COATED 500 mg 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-490 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC] 6 Current NDC, Legacy NDC, 13 package rows 20241109_201b860d-dc3c-4380-affa-e757bf2103cf.zip 50580-490 TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC] 1 Current NDC, Legacy NDC 20241204_2611e984-0dd5-bda1-e063-6394a90a559a.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 Sample Exclude flag Status 50580-490-02 50580049002 1 BOTTLE in 1 CARTON (50580-490-02) / 200 TABLET, COATED in 1 BOTTLE 1 bottle 2026-06-01 No No Current