Curodont Repair Fluoride Plus Sponge
NDC Package 72247-108-03

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

Curodont Repair Fluoride Plus (sodium fluoride) sponges is see package insert for specific instructions for product activationFrom the Curodont Repair Fluoride Plus box, retrieve one UNIT A and peel off the color.From the pouch, retrieve one UNIT B. This formulation utilizes a sponge delivery system. Marketed by Credentis Ag, this product is identified by NDC 72247-108 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
72247-108-03
Package Description
2 POUCH in 1 BOX / 5 DOSE PACK in 1 POUCH (72247-108-02) / .25 mL in 1 DOSE PACK (72247-108-01)
Product Code
72247-108
11-Digit Billing Format
72247010803

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
See package insert for specific instructions for product activationFrom the Curodont Repair Fluoride Plus box, retrieve one UNIT A and peel off the color.From the pouch, retrieve one UNIT B. Keep the remaining unused UNIT B in the pouch for future use. Do not replace UNIT B with water, saline, or any other liquid. UNIT A and UNIT B are intended to always be used together.Pour the entire contents of UNIT B into the UNIT A receptacle containing the sponge, letting it absorb the liquid for at least 5 minutes to fully activate the proprietary formulation. Meanwhile, proceed with preparing the treatment site. Each set of UNIT A and UNIT B is intended to treat one initial lesion in a single patient.Perform oral prophylaxis on the teeth to be treated, including removal of the salivary pellicle using your preferred method (pumice/prophy paste/air polisher/2% sodium hypochlorite). Rinse and dry.Etch using 35% phosphoric acid for 20 seconds. For interproximal sites, use unwaxed dental floss to apply the etchant, if needed. Rinse.After ensuring that the sponge in UNIT A is fully soaked and soft, isolate the treatment site using basic aids such as cotton rolls, saliva ejector, dry aids, etc. Rubber dam is not necessary. Use cotton pliers to firmly grip the saturated sponge in UNIT A from one of its corners.Press the sponge on the lesion surface until the formula is deposited and hte sponge starts to appear dry. Use only saturated sponge per lesion. One 'lesion' is defined as one lesion on occlusal/buccal/lingual surfaces or one interproximal site with lesions on one or both adjacent surfaces.For interproximal sites, press the saturated sponge starting from lingual embrasure, moving to the buccal and, for any residual formula, the occlusal. Separators or wedges are not needed.Wait for 5 minutes before asking the patient to expectorate residues, if any. Dispose the used UNIT A and UNIT B.Instruct the 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
12-31-2024
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 (72247-108). Click a package code to view its specific billing and regulatory data.

72247-108-04
4 POUCH in 1 BOX / 5 DOSE PACK in 1 POUCH (72247-108-02) / .25 mL in 1 DOSE PACK (72247-108-01)

* 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 72247-108-03 identifies a specific commercial package of 2 pouch in 1 box / 5 dose pack in 1 pouch (72247-108-02) / .25 ml in 1 dose pack (72247-108-01) 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 December 31, 2024. 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: 72247010803. 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)
72247-108-03
11-Digit CMS (5-4-2)
72247-0108-03

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