Home NDC 50580-457 TYLENOL Extra Strength
Product NDC 50580-457
11-digit product format 505800457
Labeler code 50580
Product ID 50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7
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 2020-07-10
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-457-10 TYLENOL Extra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 9 50580-457-10 TYLENOL Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 9 50580-457-11 TYLENOL Extra Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 9 50580-457-11 TYLENOL Extra Strength 10 in 1 CARTON TABLET, FILM COATED 10 9 50580-457-70 TYLENOL Extra Strength 700 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 700 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-457 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250221_c830320e-72ba-48ff-a4cd-250ac5650bf0.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 37 of 79 · 1,579 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 50580-457-10 50580045710 1 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2020-07-10 0000-00-00 No No Current 50580-457-11 50580045711 10 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2020-07-17 0000-00-00 No No Current 50580-457-70 50580045770 700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70) 2020-07-17 0000-00-00 No No Current