Home NDC 50580-139-08 CHILDRENS TYLENOL
Product NDC 50580-139
Requested package NDC 50580-139-08
11-digit product format 505800139
Labeler code 50580
Product ID 50580-139_5409ac69-c01e-e5d6-e063-6294a90a14b2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-28
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 CHILDRENS TYLENOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
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 307668 Internal RxNorm lookup 828555 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 50580-139-04 CHILDRENS TYLENOL 120 mL in 1 BOTTLE SUSPENSION 120 2 50580-139-04 CHILDRENS TYLENOL 1 in 1 CARTON SUSPENSION 1 2 50580-139-08 CHILDRENS TYLENOL 240 mL in 1 BOTTLE SUSPENSION 240 2 50580-139-08 CHILDRENS TYLENOL 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-139 CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC] 1 Current NDC, 4 package rows 20250429_3162733b-9382-39f1-e063-6294a90ac420.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 Sample Exclude flag Status 50580-139-08 50580013908 1 BOTTLE in 1 CARTON (50580-139-08) / 240 mL in 1 BOTTLE 1 bottle 2025-06-30 No No Current