Home NDC 63868-608 OXYMETAZOLINE HYDROCHLORIDE
Product NDC 63868-608
11-digit product format 638680608
Labeler code 63868
Product ID 63868-608_fe2fd512-7a50-4341-a82e-30fdc9eea7c9
Type HUMAN OTC DRUG
Nonproprietary name OXYMETAZOLINE HYDROCHLORIDE
Dosage form SOLUTION
Route NASAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-15
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 OXYMETAZOLINE HYDROCHLORIDE
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-608-01 OXYMETAZOLINE HYDROCHLORIDE 30 mL in 1 BOTTLE SOLUTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-608 OXYMETAZOLINE HYDROCHLORIDE SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC] 2 Current NDC, Legacy NDC, 1 package rows 20241228_aebc7cf8-aaf7-4746-89f5-a64d0be1641e.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 73 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-608-01 63868060801 30 mL in 1 BOTTLE (63868-608-01) 30 ml 2021-03-15 0000-00-00 No No Current