Home NDC 12539-146 NAFASOLINA
Product NDC 12539-146
11-digit product format 125390146
Labeler code 12539
Product ID 12539-146_463c40c9-6e49-e804-e063-6394a90a3db8
Type HUMAN OTC DRUG
Nonproprietary name Naphazoline hydrochloride
Dosage form SOLUTION/ DROPS
Route NASAL
Labeler Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-20
Substance NAPHAZOLINE HYDROCHLORIDE
Active strength 50 mg/100mL
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 NAFASOLINA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPHAZOLINE HYDROCHLORIDE 50 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MZ1131787D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046602 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 12539-146-01 NAFASOLINA 14.7868 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 14.7868 2 12539-146-02 NAFASOLINA 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12539-146 NAFASOLINA (NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DORAL PHARMAMEDICS INC DBA AG MARIN PHARMACEUTICALS] 1 Current NDC, 2 package rows 20250322_30cade3d-208f-8594-e063-6394a90ad2a0.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 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 12539-146-01 12539014601 14.7868 mL in 1 BOTTLE, DROPPER 14.7868 ml Historical 12539-146-02 12539014602 1 BOTTLE, DROPPER in 1 CARTON (12539-146-02) / 14.7868 mL in 1 BOTTLE, DROPPER (12539-146-01) 2025-03-20 No No Current