Kerasal Athletes Foot Powder Spray
NDC Package 16864-110-01

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Kerasal Athletes Foot Powder (tolnaftate) sprays is tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This formulation utilizes a spray delivery system. Marketed by Advantice Health, Llc, this product is identified by NDC 16864-110 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
16864-110-01
Package Description
57 g in 1 CAN
Product Code
16864-110
11-Digit Billing Format
16864011001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kerasal Athletes Foot Powder
Non-Proprietary Name
Tolnaftate
Substance Name
Tolnaftate
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
TOLNAFTATE 1 g/100g
Usage Information
Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Advantice Health, Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-28-2022
End Marketing Date
09-30-2026
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 16864-110-01 identifies a specific commercial package of 57 g in 1 can of Kerasal Athletes Foot Powder, a human over the counter drug labeled by Advantice Health, Llc. This spray is formulated for topical use and contains tolnaftate 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 Advantice Health, Llc on February 28, 2022.

What are the primary indications for this medication?

Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

How is this Advantice Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16864011001. 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)
16864-110-01
11-Digit CMS (5-4-2)
16864-0110-01

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