Bis Ii Tooth Paste, Dentifrice
NDC 69653-201

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 69653-201?
  4. Bis Ii Tooth Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Bis Ii Tooth (precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate) is a UNAPPROVED DRUG OTHER-approved product labeled by Jewoo Medical Co.,ltd. This medication is typically used as a blood coagulation factor [epc]. It is supplied as a paste, dentifrice for dental administration. This product entry covers the primary NDC 69653-201 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69653-201
Proprietary Name:
Bis Ii Tooth
Non-Proprietary Name: [1]
Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate
Substance Name: [2]
.alpha.-tocopherol Acetate; Alcloxa; Calcium Carbonate; Dibasic Calcium Phosphate Dihydrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Jewoo Medical Co.,ltd
Labeler Code:
69653
Product Label ID:
49f94296-3e74-1828-e063-6394a90a97d5
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]
01-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 69653-201?

The NDC code 69653-201 is assigned by the FDA to the product Bis Ii Tooth. It is commonly known by its generic name, precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate. This pharmaceutical product is labeled by Jewoo Medical Co.,ltd and is currently categorized as listed product. The medication is a paste, dentifrice administered via dental route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69653-201-01. 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?

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a tentist or physician. Do not shallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

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.
  • .ALPHA.-TOCOPHEROL ACETATE .04 g/100g - A natural tocopherol and one of the most potent antioxidant tocopherols. It exhibits antioxidant activity by virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus. It has four methyl groups on the 6-chromanol nucleus. The natural d form of alpha-tocopherol is more active than its synthetic dl-alpha-tocopherol racemic mixture.
  • ALCLOXA .04 g/100g
  • CALCIUM CARBONATE .1 g/100g - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE .04 g/100g

Which are the associated UNII Codes?

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

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".