Home NDC 50580-475-50 TYLENOL
Product NDC 50580-475
Requested package NDC 50580-475-50
11-digit product format 505800475
Labeler code 50580
Product ID 50580-475_398d8996-b523-a3cd-e063-6394a90ac2c8
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 2025-08-30
Substance ACETAMINOPHEN
Active strength 325 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
Brand name suffix Regular Strength
Listing expiration 2026-12-31 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 50580-475-10 TYLENOLRegular Strength 1 in 1 CARTON TABLET, FILM COATED 1 1 50580-475-10 TYLENOLRegular Strength 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1 50580-475-11 TYLENOLRegular Strength 10 in 1 CARTON TABLET, FILM COATED 10 1 50580-475-11 TYLENOLRegular Strength 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 50580-475-50 TYLENOLRegular Strength 50 in 1 BOTTLE TABLET, FILM COATED 50 1 50580-475-50 TYLENOLRegular Strength 1 in 1 CARTON TABLET, FILM COATED 1 1
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 50580-475-50 50580047550 1 BOTTLE in 1 CARTON (50580-475-50) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-08-30 No No Current