Home NDC 50580-414 TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT
Product NDC 50580-414
11-digit product format 505800414
Labeler code 50580
Product ID 50580-414_21ab6663-3be6-9926-e063-6294a90aa5db
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-18
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 DAY/NIGHT
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 1086991 Internal RxNorm lookup 1110988 Internal RxNorm lookup 2634819 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 50580-414-03 TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT 3 in 1 CELLO PACK KIT 3 17 50580-414-04 TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT 1 in 1 CARTON KIT 1 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-414 TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] 17 Current NDC, Legacy NDC, 2 package rows 20241109_2ddb86a8-e34c-4a03-a60a-d3fedaf90608.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2634819 {1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack GPCK 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 2634819 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack PSN 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet PSN 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 2634819 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack SY 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1086991 APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 17
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-414-03 50580041403 3 CARTON in 1 CELLO PACK (50580-414-03) / 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK 3 carton 2016-07-18 0000-00-00 No No Current 50580-414-04 50580041404 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2018-12-21 0000-00-00 No No Current