NDC Package 85398-013-01 Hermon Balanitis Cream

Sulfur 1x Hpus Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
85398-013-01
Package Description:
58 g in 1 BOTTLE
Product Code:
Proprietary Name:
Hermon Balanitis Cream
Non-Proprietary Name:
Sulfur 1x Hpus
Substance Name:
Sulfur; Symphytum Officinale Whole
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.
11-Digit NDC Billing Format:
85398001301
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Beautivity Llc
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Sample Package:
No
FDA Application Number:
M005
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
09-15-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 85398-013-01?

The NDC Packaged Code 85398-013-01 is assigned to a package of 58 g in 1 bottle of Hermon Balanitis Cream, a human over the counter drug labeled by Beautivity Llc. The product's dosage form is cream and is administered via topical form.

Is NDC 85398-013 included in the NDC Directory?

Yes, Hermon Balanitis Cream with product code 85398-013 is active and included in the NDC Directory. The product was first marketed by Beautivity Llc on September 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85398-013-01?

The 11-digit format is 85398001301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-285398-013-015-4-285398-0013-01