Hermon Balanitis Relief Kit
NDC Package 85398-014-01

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

Package Information

Hermon Balanitis Relief Kit (sulfur 1x hpus) kits is for Cream: Apply a thin layer to clean, dry skin 1-2 times daily or as needed.For first-time users,test on a small patch of skin before full application.Massage gently until fully absorbed.For bestresults, use after cleansing with the antifungal soap. This formulation utilizes a kit delivery system. Marketed by Beautivity Llc, this product is identified by NDC 85398-014 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85398-014-01
Package Description
1 KIT in 1 CARTON * 116 g in 1 CARTON (85398-011-01) * 58 g in 1 BOTTLE (85398-013-01)
Product Code
85398-014
11-Digit Billing Format
85398001401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hermon Balanitis Relief Kit
Non-Proprietary Name
Sulfur 1x Hpus
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
For Cream: Apply a thin layer to clean, dry skin 1-2 times daily or as needed.For first-time users,test on a small patch of skin before full application.Massage gently until fully absorbed.For bestresults, use after cleansing with the antifungal soap. For Soap Bar: Wash affected area and dry thoroughly.Allow the lather to remain on skin for 1-2minutes before rinsing. Ensure the affected area is dried completely before applying cream.Use 1-2times daily or directed by doctor.

Regulatory & Marketing

Labeler Name
Beautivity Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-17-2025
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 85398-014-01 identifies a specific commercial package of 1 kit in 1 carton * 116 g in 1 carton (85398-011-01) * 58 g in 1 bottle (85398-013-01) of Hermon Balanitis Relief Kit, a human over the counter drug labeled by Beautivity Llc. This kit is formulated for topical use and contains 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 Beautivity Llc on September 17, 2025. The current certification is valid through December 31, 2026.

How is this Beautivity Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85398001401. 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)
85398-014-01
11-Digit CMS (5-4-2)
85398-0014-01

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