Fifthpulse Clotrimazole Cream 4oz Cream
NDC Package 69571-019-01

11-digit billing NDC: 69571001901
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fifthpulse Clotrimazole Cream 4oz (clotrimazole 1%) cream is classified as a

administered via topical route. This formulation utilizes a cream delivery system. Marketed by Front Pharmaceutical Plc, this product is identified by NDC 69571-019 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
69571-019-01
Package Description
113.4 g in 1 TUBE
Product Code
69571-019
11-Digit Billing Format
69571001901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fifthpulse Clotrimazole Cream 4oz
Non-Proprietary Name
Clotrimazole 1%
Substance Name
Clotrimazole
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)
CLOTRIMAZOLE 1 g/100g
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Front Pharmaceutical Plc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-19-2025
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 69571-019-01 identifies a specific commercial package of 113.4 g in 1 tube of Fifthpulse Clotrimazole Cream 4oz, a human over the counter drug labeled by Front Pharmaceutical Plc. This cream is formulated for topical use and contains clotrimazole 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 Front Pharmaceutical Plc on July 19, 2025. The current certification is valid through December 31, 2026.

How is this Front Pharmaceutical Plc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69571001901. 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)
69571-019-01
11-Digit CMS (5-4-2)
69571-0019-01

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