Antibacterial Gel For Men Gel
NDC Package 84260-011-01

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

Package Information

Antibacterial Gel For Men (clove, sophora flavescens root, polyaminopropyl biguanide) gel is men's antibacterial gel. This formulation utilizes a gel delivery system. Marketed by Guangzhou Lvying Biotechnology Co.,ltd, this product is identified by NDC 84260-011 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
84260-011-01
Package Description
3 g in 1 TUBE
Product Code
84260-011
11-Digit Billing Format
84260001101

Clinical Specifications

Proprietary Name
Antibacterial Gel For Men
Non-Proprietary Name
Clove, Sophora Flavescens Root, Polyaminopropyl Biguanide
Substance Name
Clove; Polyaminopropyl Biguanide; Sophora Flavescens Root
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)
Pharmacologic Class
Usage Information
Men's antibacterial gel

Regulatory & Marketing

Labeler Name
Guangzhou Lvying Biotechnology Co.,ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-26-2025
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 84260-011-01 identifies a specific commercial package of 3 g in 1 tube of Antibacterial Gel For Men, a human over the counter drug labeled by Guangzhou Lvying Biotechnology Co.,ltd. This gel is formulated for topical use and contains clove; polyaminopropyl biguanide; sophora flavescens root 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 Guangzhou Lvying Biotechnology Co.,ltd on March 26, 2025. The current certification is valid through December 31, 2026.

How is this Guangzhou Lvying Biotechnology Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84260001101. 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)
84260-011-01
11-Digit CMS (5-4-2)
84260-0011-01

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