Home NDC 50580-659 Sudafed Sinus Congestion Plus Cold Severe Day
Product NDC 50580-659
11-digit product format 505800659
Labeler code 50580
Product ID 50580-659_537e1a0d-820e-c3f7-e063-6294a90a56ea
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Pseudoephedrine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-10
Substance PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 30; 500 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 Sudafed Sinus Congestion Plus Cold Severe Day
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N 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 1090743 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50580-659-10 50580065910 1 BLISTER PACK in 1 CARTON (50580-659-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-06-10 No No Current