Fungal Nail Patches Patch
NDC Package 85038-005-01

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

Package Information

Fungal Nail Patches (tolnaftate, undecylenic acid) patches is repairs fungal nail damage and improves nail appearance. This formulation utilizes a patch delivery system. Marketed by Lianjiang Shanlilai E-commerce Co., Ltd., this product is identified by NDC 85038-005 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85038-005-01
Package Description
20 PATCH in 1 PACKAGE / 1 PATCH in 1 PATCH
Product Code
85038-005
11-Digit Billing Format
85038000501
RxNorm Crosswalk
  • RxCUI: 2700164 - tolnaftate 1 % / undecylenic acid 25 % Medicated Patch
  • RxCUI: 2700164 - tolnaftate 0.01 MG/MG / undecylenic acid 0.25 MG/MG Medicated Patch

Clinical Specifications

Proprietary Name
Fungal Nail Patches
Non-Proprietary Name
Tolnaftate, Undecylenic Acid
Substance Name
Tolnaftate; Undecylenic Acid
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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
Repairs fungal nail damage and improves nail appearance.

Regulatory & Marketing

Labeler Name
Lianjiang Shanlilai E-commerce Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-19-2024
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 85038-005-01 identifies a specific commercial package of 20 patch in 1 package / 1 patch in 1 patch of Fungal Nail Patches, a human over the counter drug labeled by Lianjiang Shanlilai E-commerce Co., Ltd.. This patch 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 Lianjiang Shanlilai E-commerce Co., Ltd. on December 19, 2024. The current certification is valid through December 31, 2027.

How is this Lianjiang Shanlilai E-commerce Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85038000501. 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)
85038-005-01
11-Digit CMS (5-4-2)
85038-0005-01

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