Home NDC 50580-239-01 SUDAFED PE SINUS CONGESTION
Product NDC 50580-239
Requested package NDC 50580-239-01
11-digit product format 505800239
Labeler code 50580
Product ID 50580-239_216dcbdd-8eff-4427-e063-6294a90aed52
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride and phenylephrine hydrochloride
Dosage form KIT
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-17
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 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049182 Internal RxNorm lookup 1052767 Internal RxNorm lookup 1052928 Internal RxNorm lookup 2639176 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 50580-239-01 SUDAFED PE SINUS CONGESTION 1 in 1 PACKAGE KIT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-239 SUDAFED PE SINUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20241109_a38fdfb8-db89-487f-9b68-aa9152b91f5f.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 73 of 178 · 3,551 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 50580-239-01 50580023901 1 KIT in 1 PACKAGE (50580-239-01) * 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2019-06-17 0000-00-00 No No Current