Home NDC 50580-368 SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol
Product NDC 50580-368
11-digit product format 505800368
Labeler code 50580
Product ID 50580-368_33fe2091-3984-713a-e063-6394a90ad28c
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 2025-06-16
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 No Drip Nasal Mist with Cooling Menthol
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 50580-368-01 SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol 1 in 1 CARTON SPRAY 1 1 50580-368-01 SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol 30 mL in 1 BOTTLE SPRAY 30 1
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 50580-368-01 50580036801 1 BOTTLE in 1 CARTON (50580-368-01) / 30 mL in 1 BOTTLE 1 bottle 2025-06-16 No No Current