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

Additional Listing Data#

Finished product
Yes
Brand name base
NAFASOLINA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE50 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D
Rxcui1046602

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12539-146-01NAFASOLINA14.7868 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS14.78682
12539-146-02NAFASOLINA1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12539-146NAFASOLINA (NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [DORAL PHARMAMEDICS INC DBA AG MARIN PHARMACEUTICALS]1Current NDC, 2 package rows20250322_30cade3d-208f-8594-e063-6394a90ad2a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046602naphazoline HCl 0.05 % Nasal SolutionPSN30cade3d-208f-8594-e063-6394a90ad2a02
1046602naphazoline hydrochloride 0.5 MG/ML Nasal SolutionSCD30cade3d-208f-8594-e063-6394a90ad2a02
1046602naphazoline hydrochloride 0.05 % Nasal SolutionSY30cade3d-208f-8594-e063-6394a90ad2a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12539-146-011253901460114.7868 mL in 1 BOTTLE, DROPPER14.7868 mlHistorical
12539-146-02125390146021 BOTTLE, DROPPER in 1 CARTON (12539-146-02) / 14.7868 mL in 1 BOTTLE, DROPPER (12539-146-01) 2025-03-20NoNoHistorical