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  4. NDC Product Code: 0126-0070 Prevident 5000 Sensitive

NDC 0126-0070 Prevident 5000 Sensitive

Sodium Fluoride And Potassium Nitrate Gel, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0126-0070?
  5. Prevident 5000 Sensitive Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0126-0070
Proprietary Name:
Prevident 5000 Sensitive
Non-Proprietary Name: [1]
Sodium Fluoride And Potassium Nitrate
Substance Name: [2]
Potassium Nitrate; Sodium Fluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
    • Labeler Name: [5]
    Colgate Oral Pharmaceuticals, Inc.
    Labeler Code:
    0126
    Product Label ID:
    b028cfff-4946-49e8-b8bb-197ab99d0d35
    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]
    07-06-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)
    Flavor(s):
    PEPPERMINT (C73408)

    Code Structure Chart

    Product Details

    What is NDC 0126-0070?

    The NDC code 0126-0070 is assigned by the FDA to the product Prevident 5000 Sensitive which is a human prescription drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Prevident 5000 Sensitive is sodium fluoride and potassium nitrate. The product's dosage form is gel, dentifrice and is administered via dental form. The product is distributed in a single package with assigned NDC code 0126-0070-61 100 ml 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 Prevident 5000 Sensitive?

    Sodium fluoride makes teeth more resistant to decay and bacteria that cause cavities. This medication is used to prevent cavities.

    What are Prevident 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 Prevident 5000 Sensitive UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Prevident 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: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste
    • RxCUI: 637365 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste
    • RxCUI: 637365 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
    • RxCUI: 637365 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
    • RxCUI: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste

    * 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".