Stance Rinse
NDC Package 57511-0201-1

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

Package Information

Stance (0.63% stannous fluoride concentrate rinse) rinses is uses • aids in the prevention of dental decay • helps prevent gingivitis • helps control plaque bacteria • builds increasing protection against painful tooth sensitivity. This formulation utilizes a rinse delivery system. Marketed by Elevate Oral Care, this product is identified by NDC 57511-0201 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
57511-0201-1
Package Description
225 mL in 1 BOTTLE, PUMP
Product Code
57511-0201
11-Digit Billing Format
57511020101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Stance
Non-Proprietary Name
0.63% Stannous Fluoride Concentrate Rinse
Substance Name
Stannous Fluoride
Dosage Form
Rinse - A liquid used to cleanse by flushing.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
STANNOUS FLUORIDE 1.2 mg/mL
Usage Information
Uses • aids in the prevention of dental decay • helps prevent gingivitis • helps control plaque bacteria • builds increasing protection against painful tooth sensitivity

Regulatory & Marketing

Labeler Name
Elevate Oral Care
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-25-2016
Listing Expiration
12-31-2027
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 57511-0201-1 identifies a specific commercial package of 225 ml in 1 bottle, pump of Stance, a human over the counter drug labeled by Elevate Oral Care. This rinse is formulated for topical 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 Elevate Oral Care on August 25, 2016. The current certification is valid through December 31, 2027.

How is this Elevate Oral Care product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57511020101. 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)
57511-0201-1
11-Digit CMS (5-4-2)
57511-0201-01

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