Formula 3
NDC Package 54291-036-01

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.

Formula 3 is for treatment of athlete's foot and ringwormClean the affected area and dry thoroughly. Marketed by Canadian Custom Packaging Company, this product is identified by NDC 54291-036 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
54291-036-01
Package Description
1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
Product Code
54291-036
11-Digit Billing Format
54291003601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Formula 3
Dosage Form
-
Usage Information
For treatment of athlete's foot and ringwormClean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on scalp or nail.To prevent athlete's foot:Clean the feet and dry thoroughly.Apply a thin layer of the product to the feet once or twice daily (morning and/or night)Supervise children in the use of this product.Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Regulatory & Marketing

Labeler Name
Canadian Custom Packaging Company
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-30-2012
Listing Expiration
12-31-2025
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 54291-036-01 identifies a specific commercial package of 1 bottle in 1 box / 15 ml in 1 bottle of Formula 3, labeled by Canadian Custom Packaging Company. 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 Canadian Custom Packaging Company on October 30, 2012. The current certification is valid through December 31, 2025.

How is this Canadian Custom Packaging Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54291003601. 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)
54291-036-01
11-Digit CMS (5-4-2)
54291-0036-01

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