Home NDC 13709-355 Sinufrin Decongestant
Product NDC 13709-355
11-digit product format 137090355
Labeler code 13709
Product ID 13709-355_52a2e5f9-e0a3-02f7-e063-6294a90a3ae9
Type HUMAN OTC DRUG
Nonproprietary name Nasal Congestion Relief
Dosage form SOLUTION
Route NASAL
Labeler NeilMed Pharmaceuticals Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-25
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 7.5 mg/15mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Sinufrin Decongestant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 7.5 mg/15mL
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 1313914 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 13709-355-01 Sinufrin Decongestant 1 in 1 CARTON SOLUTION 1 1 13709-355-01 Sinufrin Decongestant 15 mL in 1 BOTTLE SOLUTION 15 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 13709-355-01 13709035501 1 BOTTLE in 1 CARTON (13709-355-01) / 15 mL in 1 BOTTLE 1 bottle 2026-05-25 No No Current