Home NDC 50580-245 Childrens TYLENOL
Product NDC 50580-245
11-digit product format 505800245
Labeler code 50580
Product ID 50580-245_598dbb96-4645-0c9b-e063-6394a90ac1da
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, 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; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 160; 1; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 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
Brand name suffix COLD plus COUGH plus RUNNY NOSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL CHLORPHENIRAMINE MALEATE 1 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z 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 1086750 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-245-01 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 1 in 1 CARTON SUSPENSION 1 9 50580-245-01 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 120 mL in 1 BOTTLE SUSPENSION 120 9 50580-245-02 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 1 in 1 CARTON SUSPENSION 1 9 50580-245-02 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 240 mL in 1 BOTTLE SUSPENSION 240 9 50580-245-12 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 3 in 1 CARTON SUSPENSION 3 9 50580-245-12 Childrens TYLENOLCOLD plus COUGH plus RUNNY NOSE 120 mL in 1 BOTTLE SUSPENSION 120 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-245 CHILDRENS TYLENOL COLD PLUS COUGH PLUS RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [KENVUE BRANDS LLC] 9 Current NDC, Legacy NDC, 6 package rows 20250223_5b95905e-b729-4caf-921a-fc4ef815289c.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 177 · 3,534 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 50580-245-01 50580024501 1 BOTTLE in 1 CARTON (50580-245-01) / 120 mL in 1 BOTTLE 1 bottle 2017-06-26 0000-00-00 No No Current 50580-245-02 50580024502 1 BOTTLE in 1 CARTON (50580-245-02) / 240 mL in 1 BOTTLE 1 bottle 2024-08-28 No No Current 50580-245-12 50580024512 3 BOTTLE in 1 CARTON (50580-245-12) / 120 mL in 1 BOTTLE 3 bottle 2024-08-01 No No Current