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  4. NDC Product Code: 47649-1401 Dr.whitiss 15%

NDC 47649-1401 Dr.whitiss 15%

Carbamide Peroxide,Sodium Fluoride Gel, Dentifrice Dental - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 47649-1401?
  4. Dr.whitiss 15% Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
47649-1401
Proprietary Name:
Dr.whitiss 15%
Non-Proprietary Name: [1]
Carbamide Peroxide, Sodium Fluoride
Substance Name: [2]
Carbamide Peroxide; Sodium Fluoride
NDC Directory Status:
Human Otc 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]
    Nibec Co., Ltd.
    Labeler Code:
    47649
    Product Label ID:
    f3ac966f-c613-3898-e053-2995a90a49c4
    FDA Application Number: [6]
    part356
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    06-07-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 47649-1401?

    The NDC code 47649-1401 is assigned by the FDA to the product Dr.whitiss 15% which is a human over the counter drug product labeled by Nibec Co., Ltd.. The generic name of Dr.whitiss 15% is carbamide peroxide, sodium fluoride. 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 47649-1401-2 4 syringe in 1 package / 1 g in 1 syringe (47649-1401-1). 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 Dr.whitiss 15%?

    1. Gingival and general oral heath should be confirmed before treatment. 2. Brush your teeth before treatment. 3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray. 4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.) 5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes. 6. If significant sensitivity occurs, stop treatment and consult dentist.

    What are Dr.whitiss 15% 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.
    • CARBAMIDE PEROXIDE 150 mg/g - A urea peroxide compound that is commonly used in tooth whitening agents; topical anti-infective agents, and earwax remover.
    • SODIUM FLUORIDE 2.5 mg/g - A source of inorganic fluoride which is used topically to prevent dental caries.

    Which are Dr.whitiss 15% UNII Codes?

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

    Which are Dr.whitiss 15% 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 Dr.whitiss 15%?

    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: 2265639 - carbamide peroxide 15 % / sodium fluoride 0.25 % Oral Gel
    • RxCUI: 2265639 - carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Oral Gel
    • RxCUI: 2265639 - carbamide peroxide 0.15 MG/MG / sodium fluoride 0.0025 MG/MG Dental Gel

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    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".