Sodium Fluoride Solution/ Drops
NDC Package 58657-322-50

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

Package Information

Sodium Fluoride solution/ dropses is a medication used to prevent cavities. This formulation utilizes a solution/ drops delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-322.

Identification & Billing

NDC Package Code
58657-322-50
Package Description
50 mL in 1 BOTTLE, DROPPER
Product Code
58657-322
11-Digit Billing Format
58657032250
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Fluoride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .5 mg/mL
Usage Information
This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
08-15-2018
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 58657-322-50 identifies a specific commercial package of 50 ml in 1 bottle, dropper of Sodium Fluoride, a human prescription drug labeled by Method Pharmaceuticals, Llc. This solution/ drops is formulated for oral 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 Method Pharmaceuticals, Llc on August 15, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

How is this Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657032250. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 total billable units per package. 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)
58657-322-50
11-Digit CMS (5-4-2)
58657-0322-50

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