Fungal Nail Treatment Liquid
NDC Package 85308-003-01

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

Package Information

Fungal Nail Treatment liquids is 1. This formulation utilizes a liquid delivery system. Marketed by Gaoye Marketing Inc, this product is identified by NDC 85308-003 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85308-003-01
Package Description
30 mL in 1 BOTTLE
Product Code
85308-003
11-Digit Billing Format
85308000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fungal Nail Treatment
Non-Proprietary Name
Fungal Nail Treatment
Substance Name
Undecylenic Acid
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
UNDECYLENIC ACID 25 g/100mL
Usage Information
1. Apply the product twice a day, in the morning and at night. 2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days. 3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas. 4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.

Regulatory & Marketing

Labeler Name
Gaoye Marketing Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-12-2025
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 85308-003-01 identifies a specific commercial package of 30 ml in 1 bottle of Fungal Nail Treatment, a human over the counter drug labeled by Gaoye Marketing Inc. This liquid is formulated for topical use and contains undecylenic acid 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 Gaoye Marketing Inc on April 12, 2025. The current certification is valid through December 31, 2026.

How is this Gaoye Marketing Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85308000301. 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)
85308-003-01
11-Digit CMS (5-4-2)
85308-0003-01

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