Nafasolina Solution/ Drops
NDC Package 12539-146-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nafasolina (naphazoline hydrochloride) solution/ dropses is naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis. This formulation utilizes a solution/ drops delivery system. Marketed by Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals, this product is identified by NDC 12539-146 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
12539-146-02
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 14.7868 mL in 1 BOTTLE, DROPPER (12539-146-01)
Product Code
12539-146
11-Digit Billing Format
12539014602
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nafasolina
Non-Proprietary Name
Naphazoline Hydrochloride
Substance Name
Naphazoline Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
NAPHAZOLINE HYDROCHLORIDE 50 mg/100mL
Usage Information
Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis. Temporarily relieves a stuffy nose. Helps clear nasal passages.

Regulatory & Marketing

Labeler Name
Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-20-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12539-146-02 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 14.7868 ml in 1 bottle, dropper (12539-146-01) of Nafasolina, a human over the counter drug labeled by Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals. This solution/ drops is formulated for nasal use and contains naphazoline hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals on March 20, 2025. The current certification is valid through December 31, 2026.

How is this Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12539014602. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
12539-146-02
11-Digit CMS (5-4-2)
12539-0146-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.