Lunavia Antifungal Foot Balm Ointment
NDC Package 85210-003-01

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

Package Information

Lunavia Antifungal Foot Balm (zinc undecylenate 10%) ointment is apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor. This formulation utilizes a ointment delivery system. Marketed by Xf Agencija Limited, this product is identified by NDC 85210-003 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85210-003-01
Package Description
1 BOTTLE in 1 BOX / 57 g in 1 BOTTLE
Product Code
85210-003
11-Digit Billing Format
85210000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lunavia Antifungal Foot Balm
Non-Proprietary Name
Zinc Undecylenate 10%
Substance Name
Zinc Undecylenate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
ZINC UNDECYLENATE 10 g/100g
Usage Information
Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.

Regulatory & Marketing

Labeler Name
Xf Agencija Limited
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-13-2025
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 85210-003-01 identifies a specific commercial package of 1 bottle in 1 box / 57 g in 1 bottle of Lunavia Antifungal Foot Balm, a human over the counter drug labeled by Xf Agencija Limited. This ointment is formulated for topical use and contains zinc undecylenate 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 Xf Agencija Limited on June 13, 2025. The current certification is valid through December 31, 2026.

How is this Xf Agencija Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85210000301. 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)
85210-003-01
11-Digit CMS (5-4-2)
85210-0003-01

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