Cloveden Vegan Whitening Tooth Paste, Dentifrice
NDC Package 84516-030-02

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

Package Information

Cloveden Vegan Whitening Tooth (silica, hydrogen peroxide, tocopheryl acetate) pastes is use(s)■ Whitens teeth.■ Prevents cavities and eliminates bad breath.■ Strengthens teeth.■ Keeps the oral cavity clean.■ Refreshes the oral cavity.■ Enhance the aesthetic effect.■ Prevention of gingivitis, periodontitis (pyorrhoea).■ Prevention of periodontal disease.■ prevention of gum disease.■ Remove dental plaque (anti-prag). This formulation utilizes a paste, dentifrice delivery system. Marketed by Acuseplanet Inc, this product is identified by NDC 84516-030.

Identification & Billing

NDC Package Code
84516-030-02
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE (84516-030-01)
Product Code
84516-030
11-Digit Billing Format
84516003002

Clinical Specifications

Proprietary Name
Cloveden Vegan Whitening Tooth
Non-Proprietary Name
Silica, Hydrogen Peroxide, Tocopheryl Acetate
Substance Name
.alpha.-tocopherol Acetate; Hydrogen Peroxide; Silicon Dioxide
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Use(s)■ Whitens teeth.■ Prevents cavities and eliminates bad breath.■ Strengthens teeth.■ Keeps the oral cavity clean.■ Refreshes the oral cavity.■ Enhance the aesthetic effect.■ Prevention of gingivitis, periodontitis (pyorrhoea).■ Prevention of periodontal disease.■ prevention of gum disease.■ Remove dental plaque (anti-prag)

Regulatory & Marketing

Labeler Name
Acuseplanet Inc
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
08-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84516-030-02 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube (84516-030-01) of Cloveden Vegan Whitening Tooth, a human over the counter drug labeled by Acuseplanet Inc. This paste, dentifrice is formulated for oral use and contains .alpha.-tocopherol acetate; hydrogen peroxide; silicon dioxide 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 Acuseplanet Inc on August 01, 2025. The current certification is valid through December 31, 2026.

How is this Acuseplanet Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84516003002. 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)
84516-030-02
11-Digit CMS (5-4-2)
84516-0030-02

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