Penetral Roll-on Gel
NDC Package 59088-329-07

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

Package Information

Penetral Roll-on (capsaicin 0.025%) gel is ■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily■ Children under 2 years of age: do not use, consult a doctor■ Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes. This formulation utilizes a gel delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-329 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
59088-329-07
Package Description
85 g in 1 BOTTLE
Product Code
59088-329
11-Digit Billing Format
59088032907

Clinical Specifications

Proprietary Name
Penetral Roll-on
Non-Proprietary Name
Capsaicin 0.025%
Substance Name
Capsicum Oleoresin
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
CAPSICUM OLEORESIN .25 mg/g
Usage Information
■ Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily■ Children under 2 years of age: do not use, consult a doctor■ Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-14-2026
Listing Expiration
12-31-2027
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 59088-329-07 identifies a specific commercial package of 85 g in 1 bottle of Penetral Roll-on, a human over the counter drug labeled by Puretek Corporation. This gel is formulated for topical use and contains capsicum oleoresin 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 Puretek Corporation on July 14, 2026. The current certification is valid through December 31, 2027.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088032907. 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)
59088-329-07
11-Digit CMS (5-4-2)
59088-0329-07

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