Periorestore Gel
NDC Package 59883-018-87

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

Package Information

Periorestore (hydrogen peroxide) gel is for temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. This formulation utilizes a gel delivery system. Marketed by Den-mat Holdings, Llc., this product is identified by NDC 59883-018 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
59883-018-87
Package Description
1 TUBE in 1 BOX / 85 g in 1 TUBE
Product Code
59883-018
11-Digit Billing Format
59883001887
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Periorestore
Non-Proprietary Name
Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
HYDROGEN PEROXIDE 17 mg/g
Usage Information
For temporary use in cleansing minor wounds and retreatment of inflammation resulting from dental procedures, or other irritations of the mouth and gums. Perio Restore may be used for lessening the presence of plaque, a known factor in development of gingivitis.

Regulatory & Marketing

Labeler Name
Den-mat Holdings, Llc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2019
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 59883-018-87 identifies a specific commercial package of 1 tube in 1 box / 85 g in 1 tube of Periorestore, a human over the counter drug labeled by Den-mat Holdings, Llc.. This gel is formulated for dental 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 Den-mat Holdings, Llc. on July 15, 2019. The current certification is valid through December 31, 2026.

How is this Den-mat Holdings, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59883001887. 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)
59883-018-87
11-Digit CMS (5-4-2)
59883-0018-87

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