Cloveden 100 Times Higher Concentrated Mouthwash
NDC Package 84516-040-02

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

Package Information

Cloveden 100 Times Higher Concentrated (cetylpyridinium chloride) mouthwashes is use(s)■ Refreshing the mouth■ Plaque removal■ Oral cleanliness■ Bad breath removal. This formulation utilizes a mouthwash delivery system. Marketed by Acuseplanet Inc, this product is identified by NDC 84516-040 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84516-040-02
Package Description
1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE (84516-040-01)
Product Code
84516-040
11-Digit Billing Format
84516004002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cloveden 100 Times Higher Concentrated
Non-Proprietary Name
Cetylpyridinium Chloride
Substance Name
Cetylpyridinium Chloride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE 2.29 g/100mL
Usage Information
Use(s)■ Refreshing the mouth■ Plaque removal■ Oral cleanliness■ Bad breath removal

Regulatory & Marketing

Labeler Name
Acuseplanet Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
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 84516-040-02 identifies a specific commercial package of 1 bottle in 1 carton / 50 ml in 1 bottle (84516-040-01) of Cloveden 100 Times Higher Concentrated, a human over the counter drug labeled by Acuseplanet Inc. This mouthwash is formulated for oral use and contains cetylpyridinium chloride 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: 84516004002. 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)
84516-040-02
11-Digit CMS (5-4-2)
84516-0040-02

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