Mipaste One Perio Paste, Dentifrice
NDC Package 61596-300-10

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

Package Information

Mipaste One Perio pastes is uses • Helps prevent gingivitis • Helps interfere with harmful effects of plaque associated with gingivitis • Aids in the prevention of cavities • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. This formulation utilizes a paste, dentifrice delivery system. Marketed by Gc America Inc., this product is identified by NDC 61596-300 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
61596-300-10
Package Description
10 BOTTLE, UNIT-DOSE in 1 BOX / 1 TUBE in 1 BOTTLE, UNIT-DOSE (61596-300-41) / 42 g in 1 TUBE (61596-300-40)
Product Code
61596-300
11-Digit Billing Format
61596030010
RxNorm Crosswalk
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Mipaste One Perio
Non-Proprietary Name
Mipaste One Perio
Substance Name
Stannous Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
STANNOUS FLUORIDE .454 g/100g
Usage Information
Uses • Helps prevent gingivitis • Helps interfere with harmful effects of plaque associated with gingivitis • Aids in the prevention of cavities • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Regulatory & Marketing

Labeler Name
Gc America Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2022
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 61596-300-10 identifies a specific commercial package of 10 bottle, unit-dose in 1 box / 1 tube in 1 bottle, unit-dose (61596-300-41) / 42 g in 1 tube (61596-300-40) of Mipaste One Perio, a human over the counter drug labeled by Gc America Inc.. This paste, dentifrice is formulated for dental use and contains stannous fluoride 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 Gc America Inc. on February 01, 2022. The current certification is valid through December 31, 2026.

How is this Gc America Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61596030010. 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)
61596-300-10
11-Digit CMS (5-4-2)
61596-0300-10

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