NDC 0135-0643 Sensodyne Extra Whitening Cool Mint

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

Product Information

NDC Product Code:
0135-0643
Proprietary Name:
Sensodyne Extra Whitening Cool Mint
Non-Proprietary Name: [1]
Potassium Nitrate And Sodium Fluoride
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 - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Dental - Administration to a tooth or teeth.
  • Labeler Name: [5]
    Haleon Us Holdings Llc
    Labeler Code:
    0135
    FDA Application Number: [6]
    M022
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    04-03-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Flavor(s):
    MINT (C73404 - COOL)

    Product Packages

    NDC Code 0135-0643-01

    Package Description: 1 TUBE in 1 CARTON / 113 g in 1 TUBE

    Product Details

    What is NDC 0135-0643?

    The NDC code 0135-0643 is assigned by the FDA to the product Sensodyne Extra Whitening Cool Mint which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Sensodyne Extra Whitening Cool Mint is potassium nitrate and sodium fluoride. The product's dosage form is paste and is administered via dental form. The product is distributed in a single package with assigned NDC code 0135-0643-01 1 tube in 1 carton / 113 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 Sensodyne Extra Whitening Cool Mint?

    •adults and children 12 years of age and older:•apply at least a 1-inch strip of the product onto a soft bristle toothbrush.•brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.•children under 12 years of age: Consult a dentist or doctor.

    What are Sensodyne Extra Whitening Cool Mint 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 Sensodyne Extra Whitening Cool Mint UNII Codes?

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

    Which are Sensodyne Extra Whitening Cool Mint 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 Sensodyne Extra Whitening Cool Mint?

    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: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste
    • RxCUI: 1038929 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste
    • RxCUI: 1038929 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
    • RxCUI: 1038929 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
    • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) 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.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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".