Maintenance Rinse
NDC Package 61578-313-01

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

Package Information

Maintenance Rinse (anticaries) rinses is adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. This formulation utilizes a rinse delivery system. Marketed by Dental Alliance Holdings Llc, this product is identified by NDC 61578-313 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
61578-313-01
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
61578-313
11-Digit Billing Format
61578031301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Maintenance Rinse Grape
Non-Proprietary Name
Anticaries
Substance Name
Sodium Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 226 ug/mL
Usage Information
Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.

Regulatory & Marketing

Labeler Name
Dental Alliance Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-10-2022
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 61578-313-01 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Maintenance Rinse Grape, a human over the counter drug labeled by Dental Alliance Holdings Llc. This rinse is formulated for dental use and contains sodium 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 Dental Alliance Holdings Llc on May 10, 2022. The current certification is valid through December 31, 2026.

How is this Dental Alliance Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61578031301. 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)
61578-313-01
11-Digit CMS (5-4-2)
61578-0313-01

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