Home NDC 45802-410 oxymetazoline hcl
Product NDC 45802-410
11-digit product format 458020410
Labeler code 45802
Product ID 45802-410_999f909c-4119-4f4e-9093-6438801b878d
Type HUMAN OTC DRUG
Nonproprietary name oxymetazoline hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-12-05
Marketing end 2027-02-28
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 g/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
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 hcl Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 g/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 45802-410-59 oxymetazoline hcl 30 mL in 1 BOTTLE, SPRAY SPRAY 30 7 45802-410-59 oxymetazoline hcl 1 in 1 CARTON SPRAY 1 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-410 OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 2 package rows 20240912_a1103cd8-344b-4a65-8a60-3c7be86d01a6.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 45802-410-59 45802041059 1 BOTTLE, SPRAY in 1 CARTON (45802-410-59) / 30 mL in 1 BOTTLE, SPRAY 2005-12-05 2027-02-28 No No Current