Home NDC 50580-692-01 TYLENOL
Product NDC 50580-692
Requested package NDC 50580-692-01
11-digit product format 505800692
Labeler code 50580
Product ID 50580-692_21c193b9-6b79-f35c-e063-6394a90adbfe
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 2018-08-06
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
Brand name suffix 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 50580-692-01 TYLENOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7 50580-692-01 TYLENOLExtra Strength 24 in 1 BOTTLE TABLET, FILM COATED 24 7 50580-692-02 TYLENOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7 50580-692-02 TYLENOLExtra Strength 100 in 1 BOTTLE TABLET, FILM COATED 100 7 50580-692-03 TYLENOLExtra Strength 225 in 1 BOTTLE TABLET, FILM COATED 225 7 50580-692-03 TYLENOLExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-692 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC] 7 Current NDC, Legacy NDC, 6 package rows 20241109_dd87e342-b0cb-4111-9f15-415dbcda4b77.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 75 of 79 · 1,570 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 50580-692-01 50580069201 1 BOTTLE in 1 CARTON (50580-692-01) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-08-06 0000-00-00 No No Current