Treatonic Antifungal Pen Gel
NDC Package 85569-017-01

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

Package Information

Treatonic Antifungal Pen (25% undecylenic acid) gel is clean the affected area and dry thoroughly.Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product. This formulation utilizes a gel delivery system. Marketed by 100 Karma Inc, this product is identified by NDC 85569-017 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85569-017-01
Package Description
3 BOTTLE, DROPPER in 1 CARTON / 3 g in 1 BOTTLE, DROPPER
Product Code
85569-017
11-Digit Billing Format
85569001701

Clinical Specifications

Proprietary Name
Treatonic Antifungal Pen
Non-Proprietary Name
25% Undecylenic Acid
Substance Name
Undecylenic Acid
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 2.25 g/9g
Usage Information
Clean the affected area and dry thoroughly.Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.If condition persists longer,consult a doctor. This product is not effective on the scalp or nails.

Regulatory & Marketing

Labeler Name
100 Karma Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-18-2026
Listing Expiration
12-31-2027
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 85569-017-01 identifies a specific commercial package of 3 bottle, dropper in 1 carton / 3 g in 1 bottle, dropper of Treatonic Antifungal Pen, a human over the counter drug labeled by 100 Karma Inc. This gel 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 100 Karma Inc on June 18, 2026. The current certification is valid through December 31, 2027.

How is this 100 Karma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85569001701. 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)
85569-017-01
11-Digit CMS (5-4-2)
85569-0017-01

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