NDC 55346-0943 Alpha-pro

Sodium Fluoride And Hydrofluoric Acid Gel Dental - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
55346-0943
Proprietary Name:
Alpha-pro
Non-Proprietary Name: [1]
Sodium Fluoride And Hydrofluoric Acid
Substance Name: [2]
Hydrofluoric Acid; Sodium Fluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
  • Labeler Name: [5]
    Dental Technologies, Inc.
    Labeler Code:
    55346
    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]
    04-01-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    ORANGE (C73406 - VANILLA ORANGE)

    Product Packages

    NDC Code 55346-0943-1

    Package Description: 497 g in 1 BOTTLE

    Product Details

    What is NDC 55346-0943?

    The NDC code 55346-0943 is assigned by the FDA to the product Alpha-pro which is a human prescription drug product labeled by Dental Technologies, Inc.. The generic name of Alpha-pro is sodium fluoride and hydrofluoric acid. The product's dosage form is gel and is administered via dental form. The product is distributed in a single package with assigned NDC code 55346-0943-1 497 g in 1 bottle . 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 Alpha-pro?

    Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times per year.

    What are Alpha-pro 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.
    • HYDROFLUORIC ACID 4.4 mg/g - Hydrofluoric acid. A solution of hydrogen fluoride in water. It is a colorless fuming liquid which can cause painful burns.
    • SODIUM FLUORIDE 7.9 mg/g - A source of inorganic fluoride which is used topically to prevent dental caries.

    Which are Alpha-pro UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Alpha-pro?

    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: 1297381 - hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel
    • RxCUI: 1297381 - hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel

    * 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".