Dermacinrx Penetral Cream
NDC Package 59088-310-08

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

Package Information

Dermacinrx Penetral Cream (capsaicin) cream is diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). This formulation utilizes a cream delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-310 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
59088-310-08
Package Description
118 mL in 1 BOTTLE, PUMP
Product Code
59088-310
11-Digit Billing Format
59088031008
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
118 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermacinrx Penetral Cream
Non-Proprietary Name
Capsaicin
Substance Name
Capsicum Oleoresin
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)
CAPSICUM OLEORESIN .25 mg/mL
Usage Information
Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-09-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59088-310). Click a package code to view its specific billing and regulatory data.

59088-310-16
237 mL in 1 BOTTLE, PUMP

* 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 59088-310-08 identifies a specific commercial package of 118 ml in 1 bottle, pump of Dermacinrx Penetral Cream, a human over the counter drug labeled by Puretek Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 118 billable units per package. This cream 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 June 09, 2015. The current certification is valid through December 31, 2026.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088031008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 118 total billable units per package. 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)
59088-310-08
11-Digit CMS (5-4-2)
59088-0310-08

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