Home NDC 50580-584 Tylenol Cold Plus Flu Plus Chest Congestion
Product NDC 50580-584
11-digit product format 505800584
Labeler code 50580
Product ID 50580-584_4e60e1ad-4ad5-c329-e063-6294a90ab318
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-06
Substance GUAIFENESIN; ACETAMINOPHEN
Active strength 200; 325 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Tylenol Cold Plus Flu Plus Chest Congestion
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 602617 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-584-10 Tylenol Cold Plus Flu Plus Chest Congestion 50 in 1 CARTON TABLET, FILM COATED 50 1 50580-584-10 Tylenol Cold Plus Flu Plus Chest Congestion 2 in 1 POUCH TABLET, FILM COATED 2 1 50580-584-24 Tylenol Cold Plus Flu Plus Chest Congestion 2 in 1 CARTON TABLET, FILM COATED 2 1 50580-584-24 Tylenol Cold Plus Flu Plus Chest Congestion 12 in 1 BLISTER PACK TABLET, FILM COATED 12 1 50580-584-50 Tylenol Cold Plus Flu Plus Chest Congestion 2 in 1 POUCH TABLET, FILM COATED 2 1 50580-584-50 Tylenol Cold Plus Flu Plus Chest Congestion 2500 in 1 CASE TABLET, FILM COATED 2500 1
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 Sample Exclude flag Status 50580-584-10 50580058410 50 in 1 CARTON Historical 50580-584-24 50580058424 2 BLISTER PACK in 1 CARTON (50580-584-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2026-03-06 No No Current 50580-584-50 50580058450 2 in 1 POUCH Historical