NDC 11527-704 Sodium Fluoride 5000 Ppm Sensitive

Sodium Fluoride1.1%,Potassium Nitrate 5% Gel, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
11527-704
Proprietary Name:
Sodium Fluoride 5000 Ppm Sensitive
Non-Proprietary Name: [1]
Sodium Fluoride1.1%, Potassium Nitrate 5%
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]
    Sheffield Pharmaceuticals Llc
    Labeler Code:
    11527
    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]
    03-26-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

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

    Product Packages

    NDC Code 11527-704-42

    Package Description: 1 TUBE in 1 CARTON / 100 mL in 1 TUBE

    Price per Unit: $0.12017 per ML

    Product Details

    What is NDC 11527-704?

    The NDC code 11527-704 is assigned by the FDA to the product Sodium Fluoride 5000 Ppm Sensitive which is a human prescription drug product labeled by Sheffield Pharmaceuticals Llc. The generic name of Sodium Fluoride 5000 Ppm Sensitive is sodium fluoride1.1%, potassium nitrate 5%. 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 11527-704-42 1 tube in 1 carton / 100 ml 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 Sodium Fluoride 5000 Ppm Sensitive?

    A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older.  It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

    What are Sodium Fluoride 5000 Ppm 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 Sodium Fluoride 5000 Ppm Sensitive UNII Codes?

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

    Which are Sodium Fluoride 5000 Ppm 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:

    * 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".