Bis Ii Tooth Paste, Dentifrice
NDC Package 69653-201-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bis Ii Tooth (precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate) pastes is adults and children 2 yrs. This formulation utilizes a paste, dentifrice delivery system. Marketed by Jewoo Medical Co.,ltd, this product is identified by NDC 69653-201.

Identification & Billing

NDC Package Code
69653-201-01
Package Description
100 g in 1 TUBE
Product Code
69653-201
11-Digit Billing Format
69653020101

Clinical Specifications

Proprietary Name
Bis Ii Tooth
Non-Proprietary Name
Precipitated Calcium Carbonate, Tocopherol Acetate, Aluminium Chlorohydroxy Allantoinate, Dibasic Calcium Phosphate Hydrate
Substance Name
.alpha.-tocopherol Acetate; Alcloxa; Calcium Carbonate; Dibasic Calcium Phosphate Dihydrate
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Jewoo Medical Co.,ltd
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-01-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69653-201-01 identifies a specific commercial package of 100 g in 1 tube of Bis Ii Tooth, a human over the counter drug labeled by Jewoo Medical Co.,ltd. This paste, dentifrice is formulated for dental use and contains .alpha.-tocopherol acetate; alcloxa; calcium carbonate; dibasic calcium phosphate dihydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Jewoo Medical Co.,ltd on January 01, 2026. The current certification is valid through December 31, 2027.

How is this Jewoo Medical Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69653020101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69653-201-01
11-Digit CMS (5-4-2)
69653-0201-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.