Gentanx Liquid
NDC Package 83243-002-01

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

Package Information

Gentanx (melissa officinalis leaf, thuja occidentalis leaf, geranium maculatum, calendula officinalis) liquids is application instructionsRemove and reverse cardboard sleeve on applicator to expose swab.Crush applicator to activate by squeezing on the “X” (in GENTANX) between thumb and forefinger until you hear a snap.Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.Discard after use.At the first sign of genital herpes outbreak (tingle): Clean the area of the tingle before applying.Apply directly to genital area at the site of the tingle.Repeat every 12 hours until all applicators are used.After genital herpes blister erupts (skin broken):Clean the area of the outbreak before applying.Apply directly to the affected area of the genitals.Repeat every 24 hours as neededChildren under 12: Ask a doctor. This formulation utilizes a liquid delivery system. Marketed by Outbreaks, Inc., this product is identified by NDC 83243-002.

Identification & Billing

NDC Package Code
83243-002-01
Package Description
9 APPLICATOR in 1 PACKAGE / .5 mL in 1 APPLICATOR
Product Code
83243-002
11-Digit Billing Format
83243000201

Clinical Specifications

Proprietary Name
Gentanx
Non-Proprietary Name
Melissa Officinalis Leaf, Thuja Occidentalis Leaf, Geranium Maculatum, Calendula Officinalis
Substance Name
Calendula Officinalis Flower; Geranium Maculatum Root; Melissa Officinalis Leaf; Thuja Occidentalis Leaf
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
Application instructionsRemove and reverse cardboard sleeve on applicator to expose swab.Crush applicator to activate by squeezing on the “X” (in GENTANX) between thumb and forefinger until you hear a snap.Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.Discard after use.At the first sign of genital herpes outbreak (tingle): Clean the area of the tingle before applying.Apply directly to genital area at the site of the tingle.Repeat every 12 hours until all applicators are used.After genital herpes blister erupts (skin broken):Clean the area of the outbreak before applying.Apply directly to the affected area of the genitals.Repeat every 24 hours as neededChildren under 12: Ask a doctor

Regulatory & Marketing

Labeler Name
Outbreaks, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
09-07-2023
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 83243-002-01 identifies a specific commercial package of 9 applicator in 1 package / .5 ml in 1 applicator of Gentanx, a human over the counter drug labeled by Outbreaks, Inc.. This liquid is formulated for topical use and contains calendula officinalis flower; geranium maculatum root; melissa officinalis leaf; thuja occidentalis leaf 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 Outbreaks, Inc. on September 07, 2023. The current certification is valid through December 31, 2026.

How is this Outbreaks, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83243000201. 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)
83243-002-01
11-Digit CMS (5-4-2)
83243-0002-01

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