Lofuanna Fungal Nail Patches Patch
NDC Package 83804-010-01

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

Package Information

Lofuanna Fungal Nail Patches (tea tree oil) patches is lofuanna Fungal Nail Patches offers a quick repair solution that works overnight in just 8 hours. This formulation utilizes a patch delivery system. Marketed by Shenzhen Shandian Jingling Technology Co., Ltd., this product is identified by NDC 83804-010 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
83804-010-01
Package Description
32 PATCH in 1 BAG / 1 PATCH in 1 PATCH
Product Code
83804-010
11-Digit Billing Format
83804001001

Clinical Specifications

Proprietary Name
Lofuanna Fungal Nail Patches
Non-Proprietary Name
Tea Tree Oil
Substance Name
Tea Tree Oil
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)
TEA TREE OIL .1 g/1
Usage Information
Lofuanna Fungal Nail Patches offers a quick repair solution that works overnight in just 8 hours. Ourpatches are hypoallergenic and specifically designed to fight fungal infections by addressing the rootcause, strengthening britle nails, and visibly reducing discoloration. The patches are easy to applyand will securely adhere to the nail.

Regulatory & Marketing

Labeler Name
Shenzhen Shandian Jingling Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-18-2025
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 83804-010-01 identifies a specific commercial package of 32 patch in 1 bag / 1 patch in 1 patch of Lofuanna Fungal Nail Patches, a human over the counter drug labeled by Shenzhen Shandian Jingling Technology Co., Ltd.. This patch is formulated for topical use and contains tea tree oil 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 Shandian Jingling Technology Co., Ltd. on November 18, 2025. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83804001001. 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)
83804-010-01
11-Digit CMS (5-4-2)
83804-0010-01

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