Home NDC 70000-0766 LEADER
Product NDC 70000-0766
11-digit product format 700000766
Labeler code 70000
Product ID 70000-0766_e7b2c1c1-6250-4af3-b131-22aced2b23d5
Type HUMAN OTC DRUG
Nonproprietary name Allergy Sinus Nasal Mist
Dosage form SPRAY
Route NASAL
Labeler CARDINAL HEALTH 110, LLC. DBA LEADER
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-01
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 mg/mL
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 LEADER
Brand name suffix No Drip
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 73 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70000-0766-1 70000076601 1 BOTTLE, SPRAY in 1 CARTON (70000-0766-1) / 30 mL in 1 BOTTLE, SPRAY 2026-07-01 No No Current