Home NDC 50580-529 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack
Product NDC 50580-529
11-digit product format 505800529
Labeler code 50580
Product ID 50580-529_22c8b85f-d4e8-f3d7-e063-6394a90ae316
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-05
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack
Listing expiration 2026-12-31 Harmonized Identifiers# Field, Values table Field Values Rxcui 1369842, 1431245, 2637731
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-369-01 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack 240 mL in 1 BOTTLE SOLUTION 240 mL 6.25 mg in 15mL 8 50580-403-08 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack 240 mL in 1 BOTTLE, PLASTIC SOLUTION 480 mL 10 mg in 30mL 8 50580-529-01 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack 1 in 1 PACKAGE KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-529 TYLENOL COLD PLUS FLU SEVERE DAY AND TYLENOL COLD PLUS FLU PLUS COUGH NIGHT 3-PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 3 package rows 20241109_464de5de-0e7a-41d6-875f-dd0e5fe7893c.zip
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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution PSN 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution PSN 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1431245 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1369842 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution SY 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1431245 acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 1369842 acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution SY 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8 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 464de5de-0e7a-41d6-875f-dd0e5fe7893c 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-369-01 50580036901 240 mL in 1 BOTTLE 240 ml Historical 50580-403-08 50580040308 240 mL in 1 BOTTLE, PLASTIC 240 ml Historical 50580-529-01 50580052901 1 KIT in 1 PACKAGE (50580-529-01) * 240 mL in 1 BOTTLE (50580-369-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) 1 kit 2019-08-05 0000-00-00 No No Current