Tooth Tablet
NDC Package 85346-001-01

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

Package Information

Tooth (toothpaste tablets) tablets is adults: Wet your toothbrush and crush the tab between your teeth. This formulation utilizes a tablet delivery system. Marketed by Henan Dailygreen Cosmetics Supplies Co.,ltd., this product is identified by NDC 85346-001.

Identification & Billing

NDC Package Code
85346-001-01
Package Description
6 BOTTLE in 1 BOX / 60 TABLET in 1 BOTTLE
Product Code
85346-001
11-Digit Billing Format
85346000101

Clinical Specifications

Proprietary Name
Tooth
Non-Proprietary Name
Toothpaste Tablets
Substance Name
Sodium Monofluorophosphate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Periodontal - Administration around a tooth.
Active Ingredient(s)
SODIUM MONOFLUOROPHOSPHATE .877 g/1001
Usage Information
Adults: Wet your toothbrush and crush the tab between your teeth. Brush like normal. Rinse after using. Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or physician. Do not swallowDirections: Bite 1 tablet and chew it into small pieces, wet your toothbrush, and brush gently. Do not swallow. Do not use if seal is broken or missing. Keep in a cool and dry place. Not suitable for children under 12.

Regulatory & Marketing

Labeler Name
Henan Dailygreen Cosmetics Supplies 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
03-13-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85346-001). Click a package code to view its specific billing and regulatory data.

85346-001-02
3 BOTTLE in 1 BOX / 60 TABLET in 1 BOTTLE

* 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 85346-001-01 identifies a specific commercial package of 6 bottle in 1 box / 60 tablet in 1 bottle of Tooth, a human over the counter drug labeled by Henan Dailygreen Cosmetics Supplies Co.,ltd.. This tablet is formulated for periodontal use and contains sodium monofluorophosphate 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 Henan Dailygreen Cosmetics Supplies Co.,ltd. on March 13, 2025. The current certification is valid through December 31, 2026.

How is this Henan Dailygreen Cosmetics Supplies Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85346000101. 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)
85346-001-01
11-Digit CMS (5-4-2)
85346-0001-01

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