NDC Package 72247-108-03 Curodont Repair Fluoride Plus

Sodium Fluoride Sponge Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
Curodont Repair Fluoride Plus
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
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.
11-Digit NDC Billing Format:
72247010803
Product Type:
Human Otc Drug
Labeler Name:
Credentis Ag
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
12-31-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
72247-108-044 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 disclaimer below.

Frequently Asked Questions

What is NDC 72247-108-03?

The NDC Packaged Code 72247-108-03 is assigned to a 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. The product's dosage form is sponge and is administered via oral form.

Is NDC 72247-108 included in the NDC Directory?

Yes, Curodont Repair Fluoride Plus with product code 72247-108 is active and included in the NDC Directory. The product was first marketed by Credentis Ag on December 31, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 72247-108-03?

The 11-digit format is 72247010803. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-272247-108-035-4-272247-0108-03