Home NDC 71205-383 Oxymethazoline HCL
Product NDC 71205-383
11-digit product format 712050383
Labeler code 71205
Product ID 71205-383_9cea7bfa-fe61-4071-a168-35e122bbe4d9
Type HUMAN OTC DRUG
Nonproprietary name Oxymethazoline HCL
Dosage form SPRAY
Route NASAL
Labeler Proficient Rx LP
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-01
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 mg/1
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 Oxymethazoline HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 mg/1
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 71205-383-30 Oxymethazoline HCL 1 in 1 CARTON SPRAY 1 4 71205-383-30 Oxymethazoline HCL 1 in 1 BOTTLE, SPRAY SPRAY 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-383 OXYMETHAZOLINE HCL SPRAY [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 2 package rows 20240125_96883e5f-18b5-4c1c-b984-756cb86be6ff.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 Marketing start Marketing end Sample Exclude flag Status 71205-383-30 71205038330 1 BOTTLE, SPRAY in 1 CARTON (71205-383-30) / 1 SPRAY in 1 BOTTLE, SPRAY 2019-01-10 0000-00-00 No No Current