Home NDC 50580-447 SUDAFED PE Head Congestion Plus Mucus
Product NDC 50580-447
11-digit product format 505800447
Labeler code 50580
Product ID 50580-447_21bd70b6-1f2f-75bc-e063-6294a90a61f3
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-17
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 SUDAFED PE Head Congestion Plus Mucus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243679 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-447-01 SUDAFED PE Head Congestion Plus Mucus 12 in 1 BLISTER PACK TABLET, FILM COATED 12 8 50580-447-01 SUDAFED PE Head Congestion Plus Mucus 2 in 1 CARTON TABLET, FILM COATED 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-447 SUDAFED PE HEAD CONGESTION PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241109_f0739186-41b9-4761-adf7-08101b30a18e.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-447-01 50580044701 2 BLISTER PACK in 1 CARTON (50580-447-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-06-17 0000-00-00 No No Current