Home NDC 50580-437 Sudafed PE Sinus Congestion
Product NDC 50580-437
11-digit product format 505800437
Labeler code 50580
Product ID 50580-437_21ad7bba-a836-8d9d-e063-6294a90a371d
Type HUMAN OTC DRUG
Nonproprietary name 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 PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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 Sinus Congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049182 Internal RxNorm lookup 1052767 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 50580-437-01 Sudafed PE Sinus Congestion 1 in 1 CARTON TABLET, FILM COATED 1 6 50580-437-01 Sudafed PE Sinus Congestion 18 in 1 BLISTER PACK TABLET, FILM COATED 18 6 50580-437-02 Sudafed PE Sinus Congestion 18 in 1 BLISTER PACK TABLET, FILM COATED 18 6 50580-437-02 Sudafed PE Sinus Congestion 2 in 1 CARTON TABLET, FILM COATED 2 6 50580-437-03 Sudafed PE Sinus Congestion 2 in 1 CARTON TABLET, FILM COATED 2 6 50580-437-03 Sudafed PE Sinus Congestion 3 in 1 PACKAGE TABLET, FILM COATED 3 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-437 SUDAFED PE SINUS CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 6 Current NDC, Legacy NDC, 6 package rows 20241109_2ca08917-1a75-4365-8520-c083e6a4225a.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 50580-437-01 50580043701 1 BLISTER PACK in 1 CARTON (50580-437-01) / 18 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2019-06-17 0000-00-00 No No Current 50580-437-02 50580043702 2 BLISTER PACK in 1 CARTON (50580-437-02) / 18 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-06-17 0000-00-00 No No Current 50580-437-03 50580043703 3 CARTON in 1 PACKAGE (50580-437-03) / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK 3 carton 2019-09-03 0000-00-00 No No Current