Dentemp Canker Cover Tablet, Extended Release
NDC Package 73653-210-08

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

Package Information

Dentemp Canker Cover (canker cover) tablets is for the temporary relief of pain associated with Canker Sores. This formulation utilizes a tablet, extended release delivery system. Marketed by Doc Brands, this product is identified by NDC 73653-210 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
73653-210-08
Package Description
8 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (73653-210-01)
Product Code
73653-210
11-Digit Billing Format
73653021008
RxNorm Crosswalk
RxCUI: 2628246 - menthol 2.5 MG Buccal Tablet

Clinical Specifications

Proprietary Name
Dentemp Canker Cover
Non-Proprietary Name
Canker Cover
Substance Name
Menthol
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • 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)
MENTHOL 2.5 mg/1
Usage Information
For the temporary relief of pain associated with Canker Sores

Regulatory & Marketing

Labeler Name
Doc Brands
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-02-2023
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 73653-210-08 identifies a specific commercial package of 8 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack (73653-210-01) of Dentemp Canker Cover, a human over the counter drug labeled by Doc Brands. This tablet, extended release is formulated for oral; topical 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 Doc Brands on February 02, 2023. The current certification is valid through December 31, 2027.

How is this Doc Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73653021008. 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)
73653-210-08
11-Digit CMS (5-4-2)
73653-0210-08

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