1. Home
  2. Labeler Index
  3. Credentis Ag
  4. NDC Product Code: 72247-108 Curodont Repair Fluoride Plus

NDC 72247-108 Curodont Repair Fluoride Plus

Sodium Fluoride Sponge Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 72247-108?
  4. Curodont Repair Fluoride Plus Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Get all the details for National Drug Code (NDC) 72247-108 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
72247-108
Proprietary Name:
Curodont Repair Fluoride Plus
Non-Proprietary Name: [1]
Sodium Fluoride
Substance Name: [2]
Sodium Fluoride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Credentis Ag
Labeler Code:
72247
Product Label ID:
290c57b0-a562-0a51-e063-6294a90a0720
FDA Application Number: [6]
M021
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
12-31-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 72247-108?

The NDC code 72247-108 is assigned by the FDA to the product Curodont Repair Fluoride Plus which is a human over the counter drug product labeled by Credentis Ag. The generic name of Curodont Repair Fluoride Plus is sodium fluoride. The product's dosage form is sponge and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 72247-108-03 2 pouch in 1 box / 5 dose pack in 1 pouch (72247-108-02) / .25 ml in 1 dose pack (72247-108-01), 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). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Curodont Repair Fluoride Plus?

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.

What are Curodont Repair Fluoride Plus Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Curodont Repair Fluoride Plus UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Curodont Repair Fluoride Plus Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".