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NDC 57511-0102 Fluorimax 5000 Sensitive

1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste Paste, Dentifrice Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57511-0102?
  5. Fluorimax 5000 Sensitive Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
57511-0102
Proprietary Name:
Fluorimax 5000 Sensitive
Non-Proprietary Name: [1]
1.1% Sodium Fluoride With 5% Potassium Nitrate Toothpaste
Substance Name: [2]
Potassium Nitrate; 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]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Elevate Oral Care
    Labeler Code:
    57511
    Product Label ID:
    53bdd864-40e7-4d22-e054-00144ff88e88
    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]
    08-01-2017
    End Marketing Date: [10]
    10-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Flavor(s):
    MINT (C73404)

    Product Packages

    NDC Code 57511-0102-3

    Package Description: 96 g in 1 TUBE

    Product Details

    What is NDC 57511-0102?

    The NDC code 57511-0102 is assigned by the FDA to the product Fluorimax 5000 Sensitive which is a human over the counter drug product labeled by Elevate Oral Care. The generic name of Fluorimax 5000 Sensitive is 1.1% sodium fluoride with 5% potassium nitrate toothpaste. The product's dosage form is paste, dentifrice and is administered via topical form. The product is distributed in a single package with assigned NDC code 57511-0102-3 96 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 Fluorimax 5000 Sensitive?

    A dental caries preventive and sensitive teeth toothpaste for once daily self appied topical use. It is well established that 1.1% sodium fluoride is safe and effective as a caries preventive when applied frequently with mouthpiece applicators. Use once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.

    What are Fluorimax 5000 Sensitive 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 Fluorimax 5000 Sensitive UNII Codes?

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

    Which are Fluorimax 5000 Sensitive 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 Fluorimax 5000 Sensitive?

    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: 2603764 - FluoriMax 5000 Sensitive 5 % / 1.1 % Toothpaste
    • RxCUI: 2603764 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]
    • RxCUI: 2603764 - Fluorimax Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) Toothpaste
    • RxCUI: 2603764 - K+ nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]
    • RxCUI: 2603764 - Pot nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluorimax Sensitive]

    * 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".