Oniadba Nail Fungus Treatment Pen Liquid
NDC Package 85992-004-01

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

Package Information

Oniadba Nail Fungus Treatment Pen (tolnaftate, undecylenic acid) liquids is antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling. This formulation utilizes a liquid delivery system. Marketed by Shenzhen Boyimei Technology Co., Ltd., this product is identified by NDC 85992-004 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85992-004-01
Package Description
4 TUBE, WITH APPLICATOR in 1 BOX / 5 mL in 1 TUBE, WITH APPLICATOR
Product Code
85992-004
11-Digit Billing Format
85992000401
RxNorm Crosswalk
  • RxCUI: 2691548 - tolnaftate 1 % / undecylenic acid 25 % Topical Solution
  • RxCUI: 2691548 - tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical Solution

Clinical Specifications

Proprietary Name
Oniadba Nail Fungus Treatment Pen
Non-Proprietary Name
Tolnaftate, Undecylenic Acid
Substance Name
Tolnaftate; 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)
Usage Information
Antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling

Regulatory & Marketing

Labeler Name
Shenzhen Boyimei Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-06-2025
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 85992-004-01 identifies a specific commercial package of 4 tube, with applicator in 1 box / 5 ml in 1 tube, with applicator of Oniadba Nail Fungus Treatment Pen, a human over the counter drug labeled by Shenzhen Boyimei Technology Co., Ltd.. This liquid is formulated for topical use and contains tolnaftate; 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 Shenzhen Boyimei Technology Co., Ltd. on August 06, 2025. The current certification is valid through December 31, 2026.

How is this Shenzhen Boyimei Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85992000401. 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)
85992-004-01
11-Digit CMS (5-4-2)
85992-0004-01

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