Curodont Repair Fluoride Plus Sponge
NDC Package 72247-109-12

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

Package Information

Curodont Repair Fluoride Plus (sodium fluoride) sponges is usual dosage is one treatment per tooth. This formulation utilizes a sponge delivery system. Marketed by Credentis Ag, this product is identified by NDC 72247-109 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
72247-109-12
Package Description
10 CYLINDER in 1 BOX / .1 mL in 1 CYLINDER
Product Code
72247-109
11-Digit Billing Format
72247010912

Clinical Specifications

Proprietary Name
Curodont Repair Fluoride Plus
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .02 g/100mL
Usage Information
Usual dosage is one treatment per tooth. After prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. Rinse the tooth surface with water. Remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area. After treatment time of five minutes have patient expectorate residues. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

Regulatory & Marketing

Labeler Name
Credentis Ag
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-27-2023
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 72247-109-12 identifies a specific commercial package of 10 cylinder in 1 box / .1 ml in 1 cylinder of Curodont Repair Fluoride Plus, a human over the counter drug labeled by Credentis Ag. This sponge is formulated for oral use and contains sodium fluoride 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 Credentis Ag on August 27, 2023. The current certification is valid through December 31, 2026.

How is this Credentis Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72247010912. 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)
72247-109-12
11-Digit CMS (5-4-2)
72247-0109-12

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