Home NDC 50580-231 TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack
Product NDC 50580-231
11-digit product format 505800231
Labeler code 50580
Product ID 50580-231_21d497dd-b70b-cd96-e063-6294a90afcd9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-20
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 Cold Plus Flu Severe and TYLENOL COLD MAX CoPack
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369842 Internal RxNorm lookup 1431245 Internal RxNorm lookup 2637731 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 50580-231-01 TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack 1 in 1 PACKAGE KIT 1 10 50580-403-08 TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack 240 mL in 1 BOTTLE, PLASTIC SOLUTION 480 mL 650 mg in 30mL 10 50580-571-01 TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack 240 mL in 1 BOTTLE, PLASTIC SOLUTION 240 mL 6.25 mg in 15mL 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-231 TYLENOL COLD PLUS FLU SEVERE AND TYLENOL COLD MAX COPACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] 10 Current NDC, Legacy NDC, 3 package rows 20241109_657a1e59-104c-4152-b2c9-00a8b82dc78e.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2637731 {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack GPCK 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack PSN 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution PSN 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution PSN 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1431245 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1369842 acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution SCD 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 2637731 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1431245 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1369842 acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1431245 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10 1369842 APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution SY 657a1e59-104c-4152-b2c9-00a8b82dc78e 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-231-01 50580023101 1 KIT in 1 PACKAGE (50580-231-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) * 240 mL in 1 BOTTLE, PLASTIC (50580-571-01) 1 kit 2018-08-20 0000-00-00 No No Current 50580-403-08 50580040308 240 mL in 1 BOTTLE, PLASTIC 240 ml Historical 50580-571-01 50580057101 240 mL in 1 BOTTLE, PLASTIC 240 ml Historical