Cloveden Tooth
NDC Package 84516-010-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cloveden Tooth is use(s)■ Keep your teeth white and strong■ Keep your mouth clean■ Refresh the inside of the mouth■ Prevent cavities and remove bad breath caused by fluorine.■ Increases aesthetic effect■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)■ Prevention of periodontal disease■ Prevention of gum disease■ Prevention of plaque deposition■ Removal of plaque (anti-prag). Marketed by Acuseplanet Inc, this product is identified by NDC 84516-010 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84516-010-02
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE (84516-010-01)
Product Code
84516-010
11-Digit Billing Format
84516001002
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Cloveden Tooth
Dosage Form
-
Usage Information
Use(s)■ Keep your teeth white and strong■ Keep your mouth clean■ Refresh the inside of the mouth■ Prevent cavities and remove bad breath caused by fluorine.■ Increases aesthetic effect■ Prevention of gingivitis and periodontal inflammation (alveolar abscess)■ Prevention of periodontal disease■ Prevention of gum disease■ Prevention of plaque deposition■ Removal of plaque (anti-prag)

Regulatory & Marketing

Labeler Name
Acuseplanet Inc
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2024
Listing Expiration
12-31-2025
Exclude Flag
I
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 84516-010-02 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube (84516-010-01) of Cloveden Tooth, labeled by Acuseplanet Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Acuseplanet Inc on July 01, 2024. The current certification is valid through December 31, 2025.

How is this Acuseplanet Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84516001002. 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)
84516-010-02
11-Digit CMS (5-4-2)
84516-0010-02

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