Home NDC 50580-374 Extra Strength TYLENOL Cold plus Flu Multi-Action
Product NDC 50580-374
11-digit product format 505800374
Labeler code 50580
Product ID 50580-374_21719087-b7ff-e583-e063-6394a90aa10c
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-21
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 Extra Strength TYLENOL Cold plus Flu Multi-Action
Brand name suffix 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 1089968 Internal RxNorm lookup 1250743 Internal RxNorm lookup 2558505 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 50580-374-01 Extra Strength TYLENOL Cold plus Flu Multi-ActionDay/Night 1 in 1 PACKAGE KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-374 EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY/NIGHT (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE) KIT [KENVUE BRANDS LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241109_712ba011-79aa-469b-9f0f-04a0b4b705bd.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2558505 {1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) } Pack GPCK 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 2558505 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) Pack PSN 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1089968 acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet PSN 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1250743 acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet PSN 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1089968 acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet SCD 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1250743 acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet SCD 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 2558505 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) Pack SY 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1089968 APAP 500 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet SY 712ba011-79aa-469b-9f0f-04a0b4b705bd 6 1250743 APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet SY 712ba011-79aa-469b-9f0f-04a0b4b705bd 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-374-01 50580037401 1 KIT in 1 PACKAGE (50580-374-01) * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2021-06-21 0000-00-00 No No Current