Teeth Whitening Kit Cream
NDC 83778-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 83778-002?
  4. Teeth Whitening Kit Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Teeth Whitening Kit is a UNAPPROVED DRUG OTHER-approved product labeled by Jiangxi Dentalbright Technology Co., Ltd. This medication is typically used as a acidifying activity [moa]. It is supplied as a cream for topical administration. This product entry covers the primary NDC 83778-002 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83778-002
Proprietary Name:
Teeth Whitening Kit
Non-Proprietary Name: [1]
Teeth Whitening Kit
Substance Name: [2]
Phthalimidoperoxycaproic Acid; Potassium Citrate; Tribasic Calcium Phosphate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Jiangxi Dentalbright Technology Co., Ltd
Labeler Code:
83778
Product Label ID:
0973b73d-5de9-0986-e063-6294a90a5917
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
11-05-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83778-002?

The NDC code 83778-002 is assigned by the FDA to the product Teeth Whitening Kit. This pharmaceutical product is labeled by Jiangxi Dentalbright Technology Co., Ltd and is currently categorized as listed product. The medication is a cream administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 83778-002-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

1. Dry your teeth and rinse mouthpiece before use. 2. Looking in the mirror to record which stage you are with shade guide paper. 3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower teeth. Each time use about 0.5-0.7ml. 4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds to start the treatment. (Tips: start with blue color, press again to turn red within 5 seconds; double press to turn red and blue within 5 seconds.) 5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and mouth with water and compare your teeth with shade guide paper again to see how many stages you have improved. 6. Don't eat or drink anything except water in 30 minutes after treatment.

What are Active Ingredients of this product?

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 the associated UNII Codes?

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

  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • PHOSPHATE ION (UNII: NK08V8K8HR) (Active Moiety)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Active Moiety)
  • PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C)
  • PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (Active Moiety)

Which are the Inactive Ingredients associated 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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".