NDC 0699-0155 Topex Neutral Fluoride Foam

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

Product Information

NDC Product Code:
0699-0155
Proprietary Name:
Topex Neutral Fluoride Foam
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]
    Dentsply Llc. Professional Division Trading As "sultan Healthcare"
    Labeler Code:
    0699
    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]
    01-01-1997
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Flavor(s):
    BERRY (C73365 - MIXED BERRY)

    Product Packages

    NDC Code 0699-0155-44

    Package Description: 1 CANISTER in 1 CARTON / 125 g in 1 CANISTER

    Product Details

    What is NDC 0699-0155?

    The NDC code 0699-0155 is assigned by the FDA to the product Topex Neutral Fluoride Foam which is a human prescription drug product labeled by Dentsply Llc. Professional Division Trading As "sultan Healthcare". The generic name of Topex Neutral Fluoride Foam 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 0699-0155-44 1 canister in 1 carton / 125 g in 1 canister. 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 Topex Neutral Fluoride Foam?

    Topex® Fluoride Foams are indicated for topical application to teeth to aid in the prevention of dental caries.The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.

    What are Topex Neutral Fluoride Foam 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 Topex Neutral Fluoride Foam UNII Codes?

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

    Which are Topex Neutral Fluoride Foam 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 Topex Neutral Fluoride Foam?

    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.

    [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".