Home NDC 50580-460-01 Childrens Tylenol
Product NDC 50580-460
Requested package NDC 50580-460-01
11-digit product format 505800460
Labeler code 50580
Product ID 50580-460_25b04cc9-cc56-5d5c-e063-6394a90a0eee
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen
Dosage form KIT
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-05-07
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 Childrens Tylenol
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 Internal RxNorm lookup 313820 Internal RxNorm lookup 828555 Internal RxNorm lookup 828557 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-460-01 Childrens Tylenol 1 in 1 PACKAGE KIT 1 11 50580-522-24 Childrens Tylenol 24 in 1 BOTTLE TABLET, CHEWABLE 24 160 mg 11 50580-522-24 Childrens Tylenol 1 in 1 CARTON TABLET, CHEWABLE 160 mg 11 50580-612-01 Childrens Tylenol 120 mL in 1 BOTTLE SUSPENSION 120 mL 160 mg in 5mL 11 50580-612-01 Childrens Tylenol 1 in 1 CARTON SUSPENSION 160 mg in 5mL 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-460 CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC] 11 Current NDC, Legacy NDC, 5 package rows 20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.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 Units Marketing start Marketing end Sample Exclude flag Status 50580-460-01 50580046001 1 KIT in 1 PACKAGE (50580-460-01) * 1 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50580-612-01) / 120 mL in 1 BOTTLE 1 kit 2018-05-07 0000-00-00 No No Current