Home NDC 50580-496 TYLENOL
Product NDC 50580-496
11-digit product format 505800496
Labeler code 50580
Product ID 50580-496_52cd19e4-a4b4-ecee-e063-6394a90ac33b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1999-02-01
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 50580-496-60 TYLENOLRegular Strength 1 in 1 CARTON TABLET 1 13 50580-496-60 TYLENOLRegular Strength 100 in 1 BOTTLE, PLASTIC TABLET 100 13 50580-496-98 TYLENOLRegular Strength 1 in 1 CARTON TABLET 1 13 50580-496-98 TYLENOLRegular Strength 100 in 1 BOTTLE, PLASTIC TABLET 100 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-496 TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [KENVUE BRANDS LLC] 12 Current NDC, Legacy NDC, 4 package rows 20241109_1622f694-4d63-4c56-8737-fae31f0ecfb7.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 13 of 79 · 1,579 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 50580-496-60 50580049660 1 BOTTLE, PLASTIC in 1 CARTON (50580-496-60) / 100 TABLET in 1 BOTTLE, PLASTIC 1999-02-01 0000-00-00 No No Current 50580-496-98 50580049698 1 BOTTLE, PLASTIC in 1 CARTON (50580-496-98) / 100 TABLET in 1 BOTTLE, PLASTIC 2019-05-31 0000-00-00 No No Current