Home NDC 50580-187 TYLENOL Extra Strength
Product NDC 50580-187
11-digit product format 505800187
Labeler code 50580
Product ID 50580-187_423280b2-1f17-3a41-e063-6394a90a61e6
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 2025-11-28
Substance ACETAMINOPHEN
Active strength 960 mg/30mL
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 Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 960 mg/30mL
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 50580-187-08 TYLENOL Extra Strength 240 mL in 1 BOTTLE SUSPENSION 240 1 50580-187-08 TYLENOL Extra Strength 1 in 1 CARTON SUSPENSION 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 50580-187-08 50580018708 1 BOTTLE in 1 CARTON (50580-187-08) / 240 mL in 1 BOTTLE 1 bottle 2025-11-28 No No Current