Home NDC 50580-787 SUDAFED OM Sinus Severe Original
Product NDC 50580-787
11-digit product format 505800787
Labeler code 50580
Product ID 50580-787_291005be-b77a-be4a-e063-6294a90a04f0
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline Hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Kenvue Brands LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-04
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 50 mg/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [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 OM Sinus Severe Original
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 Internal RxNorm lookup 1001081 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 50580-787-01 SUDAFED OM Sinus Severe Original 30 mL in 1 BOTTLE SPRAY 30 2 50580-787-01 SUDAFED OM Sinus Severe Original 1 in 1 CARTON SPRAY 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-787 SUDAFED OM SINUS SEVERE ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [KENVUE BRANDS LLC] 2 Current NDC, 2 package rows 20241215_1d089074-3969-ce6e-e063-6294a90aa70c.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 Sample Exclude flag Status 50580-787-01 50580078701 1 BOTTLE in 1 CARTON (50580-787-01) / 30 mL in 1 BOTTLE 1 bottle 2024-09-04 No No Current