Athletes Foot Cream
NDC Package 36800-049-01

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

Package Information

Athletes Foot (butenafine hydrochloride) cream is adults and children 12 years and older:use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. This formulation utilizes a cream delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-049 and is authorized under FDA application ANDA205181.

Identification & Billing

NDC Package Code
36800-049-01
Package Description
1 TUBE in 1 CARTON / 12 g in 1 TUBE
Product Code
36800-049
11-Digit Billing Format
36800004901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Athletes Foot
Non-Proprietary Name
Butenafine Hydrochloride
Substance Name
Butenafine Hydrochloride
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
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)
BUTENAFINE HYDROCHLORIDE 10 mg/g
Pharmacologic Class
Usage Information
Adults and children 12 years and older:use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.Apply between and around the toes1 week twice a day or 4 weeks once a dayfor jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor.wash hands after each usechildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA205181
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-2017
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 36800-049-01 identifies a specific commercial package of 1 tube in 1 carton / 12 g in 1 tube of Athletes Foot, a human over the counter drug labeled by Topco Associates Llc. This cream is formulated for topical use and contains butenafine hydrochloride 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 Topco Associates Llc on November 17, 2017. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800004901. 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)
36800-049-01
11-Digit CMS (5-4-2)
36800-0049-01

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