Dentek Canker Cover Patch, Extended Release
NDC Package 10564-0910-2

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

Package Information

Dentek Canker Cover (menthol) patches is adult and Children 5 year of age and older.The sore should be dry (pat with tissue) is possible. This formulation utilizes a patch, extended release delivery system. Marketed by Bershtel Enterprises, this product is identified by NDC 10564-0910 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
10564-0910-2
Package Description
1 PATCH, EXTENDED RELEASE in 1 CARTON
Product Code
10564-0910
11-Digit Billing Format
10564091002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dentek Canker Cover
Non-Proprietary Name
Menthol
Substance Name
Menthol
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transmucosal - Administration across the mucosa.
Active Ingredient(s)
MENTHOL 2.5 mg/194.851
Usage Information
Adult and Children 5 year of age and older.The sore should be dry (pat with tissue) is possible. Place the Canker Cover Patch on a clean, dry finger with the white side up. Place the white side on the sore and hold in place for 20 seconds. Within 30 minutes the tablet forms a clear, gel-like bandage that seals and protects the sore for hours before disolving. DO NOT REMOVE PATCH BEFORE IT DISSOLVES.

Regulatory & Marketing

Labeler Name
Bershtel Enterprises
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10564-0910-2 identifies a specific commercial package of 1 patch, extended release in 1 carton of Dentek Canker Cover, a human over the counter drug labeled by Bershtel Enterprises. This patch, extended release is formulated for transmucosal use and contains menthol 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 Bershtel Enterprises on December 01, 2015. The current certification is valid through December 31, 2026.

How is this Bershtel Enterprises product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10564091002. 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 (5-4-1)
10564-0910-2
11-Digit CMS (5-4-2)
10564-0910-02

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