Onetooth Clinic Tooth Paste
NDC Package 73527-0002-1

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

Package Information

Onetooth Clinic Tooth (silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate) pastes is brushing the teeth with a suitable amount. This formulation utilizes a paste delivery system. Marketed by Cone Medical Co., Ltd., this product is identified by NDC 73527-0002.

Identification & Billing

NDC Package Code
73527-0002-1
Package Description
20 g in 1 TUBE
Product Code
73527-0002
11-Digit Billing Format
73527000201

Clinical Specifications

Proprietary Name
Onetooth Clinic Tooth
Non-Proprietary Name
Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate
Substance Name
Alpha-tocopherol Acetate; Silicon Dioxide; Sodium Pyrophosphate
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
Brushing the teeth with a suitable amount

Regulatory & Marketing

Labeler Name
Cone 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
03-01-2021
Listing Expiration
12-31-2026
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 73527-0002-1 identifies a specific commercial package of 20 g in 1 tube of Onetooth Clinic Tooth, a human over the counter drug labeled by Cone Medical Co., Ltd.. This paste is formulated for dental use and contains alpha-tocopherol acetate; silicon dioxide; sodium pyrophosphate 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 Cone Medical Co., Ltd. on March 01, 2021. The current certification is valid through December 31, 2026.

How is this Cone Medical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73527000201. 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 (5-4-1)
73527-0002-1
11-Digit CMS (5-4-2)
73527-0002-01

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