Home NDC 68071-3858 Major Nasal Decongestant
Product NDC 68071-3858
11-digit product format 680713858
Labeler code 68071
Product ID 68071-3858_36b1eb59-ef20-3e53-e063-6294a90ab5ab
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline hydrochloride
Dosage form SPRAY
Route NASAL
Labeler NuCare Pharmaceuticals, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-31
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .5 mg/mL
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 Major Nasal Decongestant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL
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 68071-3858-3 Major Nasal Decongestant 1 in 1 CARTON SPRAY 1 1 68071-3858-3 Major Nasal Decongestant 30 mL in 1 BOTTLE, PUMP 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 Marketing start Sample Exclude flag Status 68071-3858-3 68071385803 1 BOTTLE, PUMP in 1 CARTON (68071-3858-3) / 30 mL in 1 BOTTLE, PUMP 2023-12-31 No No Current