Home NDC 50580-458-10 TYLENOL
Product NDC 50580-458
Requested package NDC 50580-458-10
11-digit product format 505800458
Labeler code 50580
Product ID 50580-458_49576408-6940-93c6-e063-6394a90a6fa8
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 2020-07-17
Substance ACETAMINOPHEN
Active strength 325 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
Brand name suffix Regular Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 209387 Internal RxNorm lookup 313782 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 50580-458-10 TYLENOLRegular Strength 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 10 50580-458-11 TYLENOLRegular Strength 10 in 1 CARTON TABLET, FILM COATED 10 10 50580-458-11 TYLENOLRegular Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10 50580-458-50 TYLENOLRegular Strength 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 10 50580-458-50 TYLENOLRegular Strength 1 in 1 CARTON TABLET, FILM COATED 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-458 TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 5 package rows 20250413_01f41fae-4abb-4b96-ab09-a7d3dfc286cd.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 50580-458-10 50580045810 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-458-10) 2020-07-17 0000-00-00 No No Current