Home NDC 50580-108 TYLENOL Extra Strength
Product NDC 50580-108
11-digit product format 505800108
Labeler code 50580
Product ID 50580-108_53536dcd-8f52-e352-e063-6294a90aa943
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 2025-10-13
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 50580-108-20 TYLENOL Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 2 50580-108-20 TYLENOL Extra Strength 200 in 1 BOTTLE TABLET, FILM COATED 200 2 50580-108-25 TYLENOL Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 2 50580-108-25 TYLENOL Extra Strength 225 in 1 BOTTLE TABLET, FILM COATED 225 2
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 50580-108-20 50580010820 1 in 1 CARTON Historical 50580-108-25 50580010825 1 BOTTLE in 1 CARTON (50580-108-25) / 225 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-10-13 No No Current