Closys Rinse
NDC Package 58578-0613-7

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

Closys (hydrogen peroxide) rinses is adults and children 12 years of age and olderUse 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children 6 years to under 12 years of age: supervise useChildren under 6 years of age: do not use. This formulation utilizes a rinse delivery system. Marketed by Rowpar Pharmaceuticals, Inc., this product is identified by NDC 58578-0613 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
58578-0613-7
Package Description
3 BOTTLE in 1 PACKAGE / 473 mL in 1 BOTTLE
Product Code
58578-0613
11-Digit Billing Format
58578061307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Closys
Non-Proprietary Name
Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROGEN PEROXIDE 1.5 g/100mL
Usage Information
Adults and children 12 years of age and olderUse 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children 6 years to under 12 years of age: supervise useChildren under 6 years of age: do not use

Regulatory & Marketing

Labeler Name
Rowpar Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-27-2025
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 (58578-0613). Click a package code to view its specific billing and regulatory data.

58578-0613-1
473 mL in 1 BOTTLE
58578-0613-5
1 BOTTLE in 1 CARTON / 473 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 58578-0613-7 identifies a specific commercial package of 3 bottle in 1 package / 473 ml in 1 bottle of Closys, a human over the counter drug labeled by Rowpar Pharmaceuticals, Inc.. This rinse is formulated for oral use and contains hydrogen peroxide 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 Rowpar Pharmaceuticals, Inc. on January 27, 2025. The current certification is valid through December 31, 2026.

How is this Rowpar Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58578061307. 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 (5-4-1)
58578-0613-7
11-Digit CMS (5-4-2)
58578-0613-07

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