Home NDC 50580-194 Childrens TYLENOL
Product NDC 50580-194
11-digit product format 505800194
Labeler code 50580
Product ID 50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Dextromethorphan Hydrobromide
Dosage form SUSPENSION
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-06-26
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 160; 5 mg/5mL; mg/5mL
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Brand name suffix COLD PLUS COUGH PLUS SORE THROAT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370113 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 50580-194-01 Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT 120 mL in 1 BOTTLE SUSPENSION 120 6 50580-194-01 Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT 1 in 1 CARTON SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-194 CHILDRENS TYLENOL COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [KENVUE BRANDS LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241109_e83f7911-22b4-4ffc-8f49-68f6acd2ebf5.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 73 of 178 · 3,551 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 50580-194-01 50580019401 1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE 1 bottle 2017-06-26 0000-00-00 No No Current