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  4. NDC Product Code: 70766-011 Mint Fluoride Tooth

NDC 70766-011 Mint Fluoride Tooth

Sodium Monofluorophosphate Paste, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70766-011?
  4. Mint Fluoride Tooth Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
70766-011
Proprietary Name:
Mint Fluoride Tooth
Non-Proprietary Name: [1]
Sodium Monofluorophosphate
Substance Name: [2]
Sodium Fluoride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
    • Labeler Name: [5]
    Yangzhou Sion Commodity Co.,ltd
    Labeler Code:
    70766
    Product Label ID:
    1fa163f3-6309-4bb3-85b8-6991d2eb758b
    FDA Application Number: [6]
    M021
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    11-13-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 70766-011?

    The NDC code 70766-011 is assigned by the FDA to the product Mint Fluoride Tooth which is a human over the counter drug product labeled by Yangzhou Sion Commodity Co.,ltd. The generic name of Mint Fluoride Tooth is sodium monofluorophosphate. The product's dosage form is paste, dentifrice and is administered via dental form. The product is distributed in 6 packages with assigned NDC codes 70766-011-02 12 pouch in 1 box / 12 tube in 1 pouch / 24 g in 1 tube, 70766-011-03 24 pouch in 1 box / 12 tube in 1 pouch / 24 g in 1 tube, 70766-011-04 144 tube in 1 box / 24 g in 1 tube, 70766-011-05 288 tube in 1 box / 24 g in 1 tube, 70766-011-06 576 tube in 1 box / 24 g in 1 tube, 70766-011-07 4 pouch in 1 box / 12 tube in 1 pouch / 24 g in 1 tube. 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 Mint Fluoride Tooth?

    Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physicianDo not swallowTo minimize wallowing, use a pea sizes amount in children under 6 yearsSupervise children's brushing

    What are Mint Fluoride Tooth 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 Mint Fluoride Tooth UNII Codes?

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

    Which are Mint Fluoride Tooth 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:

    What is the NDC to RxNorm Crosswalk for Mint Fluoride Tooth?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
    • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
    • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
    • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
    • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste

    * Please review the disclaimer below.

    Patient Education

    Fluoride


    Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".