Firefly Anticavity Fluoride Rinse
NDC Package 66923-003-34

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

Package Information

Firefly Anticavity Fluoride (sodium fluoride) rinses is adults and children 6 years of age and older:•use once a day after brushing your teeth with a toothpaste•vigorously swish 10 milliliters of rinse between your teeth for 1 minute and 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 supervisionChildren under 6 years of age: consult a dentist or doctor. This formulation utilizes a rinse delivery system. Marketed by Ranir Llc, this product is identified by NDC 66923-003 and is authorized under FDA application M008.

Identification & Billing

NDC Package Code
66923-003-34
Package Description
237 mL in 1 BOTTLE
Product Code
66923-003
11-Digit Billing Format
66923000334
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Firefly Anticavity Fluoride
Non-Proprietary Name
Sodium Fluoride
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 .5 mg/mL
Usage Information
Adults and children 6 years of age and older:•use once a day after brushing your teeth with a toothpaste•vigorously swish 10 milliliters of rinse between your teeth for 1 minute and 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 supervisionChildren under 6 years of age: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Ranir Llc
Product Type
Human Otc Drug
FDA Application #
M008
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-16-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (66923-003). Click a package code to view its specific billing and regulatory data.

66923-003-43
473 mL in 1 BOTTLE

* 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 66923-003-34 identifies a specific commercial package of 237 ml in 1 bottle of Firefly Anticavity Fluoride, a human over the counter drug labeled by Ranir 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 Ranir Llc on June 16, 2021. The current certification is valid through December 31, 2026.

How is this Ranir Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66923000334. 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)
66923-003-34
11-Digit CMS (5-4-2)
66923-0003-34

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