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  4. NDC Product Code: 59883-031 Fluoridex

NDC 59883-031 Fluoridex

Sodium Fluoride Paste, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59883-031?
  5. Fluoridex Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
59883-031
Proprietary Name:
Fluoridex
Non-Proprietary Name: [1]
Sodium Fluoride
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:
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
    • Labeler Name: [5]
    Dent-mat Holdings, Llc.
    Labeler Code:
    59883
    Product Label ID:
    601774d5-f4de-01bc-e053-2991aa0a7f4f
    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]
    12-21-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)
    Flavor(s):
    MINT (C73404 - CLEAN MINT)

    Product Packages

    NDC Code 59883-031-04

    Package Description: 1 TUBE in 1 BOX / 112 g in 1 TUBE

    NDC Code 59883-031-05

    Package Description: 24 g in 1 TUBE

    Product Details

    What is NDC 59883-031?

    The NDC code 59883-031 is assigned by the FDA to the product Fluoridex which is a human prescription drug product labeled by Dent-mat Holdings, Llc.. The generic name of Fluoridex is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form. The product is distributed in 2 packages with assigned NDC codes 59883-031-04 1 tube in 1 box / 112 g in 1 tube, 59883-031-05 24 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 Fluoridex?

    Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.

    What are Fluoridex 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 Fluoridex UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Fluoridex?

    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".