Tolnaftate
NDC Package 40002-002-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tolnaftate is clean the affected area and dry thoroughlyApply a thin layer over affected area twice a daily (morning and night) or as directed by a doctorSupervise children in the use of this productFor athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once dailyFor athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. Marketed by Nexmed (usa), Inc., this product is identified by NDC 40002-002 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
40002-002-01
Package Description
1 TUBE in 1 CARTON / 28 g in 1 TUBE (40002-002-02)
Product Code
40002-002
11-Digit Billing Format
40002000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tolnaftate D
Dosage Form
-
Usage Information
Clean the affected area and dry thoroughlyApply a thin layer over affected area twice a daily (morning and night) or as directed by a doctorSupervise children in the use of this productFor athlete’s foot, pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once dailyFor athlete’s foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. If condition persists longer consult a doctorThis product is not effective on the scalp or nails

Regulatory & Marketing

Labeler Name
Nexmed (usa), Inc.
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-15-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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 40002-002-01 identifies a specific commercial package of 1 tube in 1 carton / 28 g in 1 tube (40002-002-02) of Tolnaftate D, labeled by Nexmed (usa), Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nexmed (usa), Inc. on August 15, 2011. The current certification is valid through December 31, 2017.

How is this Nexmed (usa), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40002000201. 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)
40002-002-01
11-Digit CMS (5-4-2)
40002-0002-01

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