Home NDC 67091-378 12 Hour Original Nasal Decongestant
Product NDC 67091-378
11-digit product format 670910378
Labeler code 67091
Product ID 67091-378_36a14e66-29e9-4055-8c8b-dc76136021ce
Type HUMAN OTC DRUG
Nonproprietary name Nasal Spray
Dosage form LIQUID
Route NASAL
Labeler WinCo Foods LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-19
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 12 Hour Original Nasal Decongestant
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 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 67091-378-08 12 Hour Original Nasal Decongestant 30 mL in 1 BOTTLE, SPRAY LIQUID 30 3 67091-378-08 12 Hour Original Nasal Decongestant 1 in 1 CARTON LIQUID 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-378 12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [WINCO FOODS LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241122_b3b6065a-56da-45e9-b89d-f6553bc181c9.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 Marketing start Marketing end Sample Exclude flag Status 67091-378-08 67091037808 1 BOTTLE, SPRAY in 1 CARTON (67091-378-08) / 30 mL in 1 BOTTLE, SPRAY 2021-02-19 0000-00-00 No No Current