Duocare Clinical Oral Rinse Mouthwash
NDC Package 53329-030-07

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

Duocare Clinical Oral Rinse (cetylpyridinium chloride) mouthwashes is adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. This formulation utilizes a mouthwash delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-030 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
53329-030-07
Package Description
7 mL in 1 POUCH
Product Code
53329-030
11-Digit Billing Format
53329003007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Duocare Clinical Oral Rinse
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
CETYLPYRIDINIUM CHLORIDE 1 mg/mL
Usage Information
Adults and children 12 years of age and older: swish 7 ml of rinse between your teeth for approximately one minute and then spit out. Do not swallow the rinse.Use up to 4 times daily or as directed by dentist or doctor.children 6 years to under 12 years of age: supervise use.children under 6 years of age: consult a dentist or a doctor.

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2018
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 (53329-030). Click a package code to view its specific billing and regulatory data.

53329-030-13
59 mL 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 53329-030-07 identifies a specific commercial package of 7 ml in 1 pouch of Duocare Clinical Oral Rinse, a human over the counter drug labeled by Medline Industries, Lp. This mouthwash is formulated for dental 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 Medline Industries, Lp on November 01, 2018. The current certification is valid through December 31, 2026.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329003007. 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)
53329-030-07
11-Digit CMS (5-4-2)
53329-0030-07

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