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  4. NDC Product Code: 64778-0379 Denti-care Denti-foam Topical Sodium Fluoride Strawberry

NDC 64778-0379 Denti-care Denti-foam Topical Sodium Fluoride Strawberry

Sodium Fluoride Aerosol, Foam Dental - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64778-0379?
  5. Denti-care Denti-foam Topical Sodium Fluoride Strawberry Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
64778-0379
Proprietary Name:
Denti-care Denti-foam Topical Sodium Fluoride Strawberry
Non-Proprietary Name: [1]
Sodium Fluoride
Substance Name: [2]
Sodium Fluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
    • Labeler Name: [5]
    Amd Medicom Inc
    Labeler Code:
    64778
    Product Label ID:
    1bc6f926-b304-4ca4-9ebf-06868782b4ec
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    05-01-2003
    End Marketing Date: [10]
    05-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    STRAWBERRY (C73417)

    Product Packages

    NDC Code 64778-0379-3

    Package Description: 12 BOTTLE, SPRAY in 1 CASE / 125 g in 1 BOTTLE, SPRAY (64778-0379-1)

    Product Details

    What is NDC 64778-0379?

    The NDC code 64778-0379 is assigned by the FDA to the product Denti-care Denti-foam Topical Sodium Fluoride Strawberry which is a human prescription drug product labeled by Amd Medicom Inc. The generic name of Denti-care Denti-foam Topical Sodium Fluoride Strawberry is sodium fluoride. The product's dosage form is aerosol, foam and is administered via dental form. The product is distributed in a single package with assigned NDC code 64778-0379-3 12 bottle, spray in 1 case / 125 g in 1 bottle, spray (64778-0379-1). 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 Denti-care Denti-foam Topical Sodium Fluoride Strawberry?

    Indications: topical anti-caries preparationDirections:Following prophylaxis treatment, fill ¼ of tray with foamTo dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the trayInsert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutesRemove tray and have patient expectorate excessAdvise patient not to eat, drink or rinse for 30 minutes after the treatmentMedicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

    What are Denti-care Denti-foam Topical Sodium Fluoride Strawberry 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 Denti-care Denti-foam Topical Sodium Fluoride Strawberry UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Denti-care Denti-foam Topical Sodium Fluoride Strawberry?

    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:

    * 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.

    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".