Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor Mouthwash
NDC Package 70108-103-01

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

Package Information

Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor (sodium fluoride) mouthwashes is adults and children 6 years and older:• Use daily after you brush your teeth with toothpaste.• Rinse toothpaste from mouth prior to use.• Shake well before each use.• Twist and remove cap.• Rinse or gargle for 30 seconds with 15 ml and spit out.• Do Not swallow the rinse.• Do Not eat or drink for 30 minutes after rinsing.• Supervise children as necessary.• Children under 6 years of age, consult with a dentist or doctor. This formulation utilizes a mouthwash delivery system. Marketed by Ashtel Studios, Inc, this product is identified by NDC 70108-103 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
70108-103-01
Package Description
355 mL in 1 BOTTLE, PLASTIC
Product Code
70108-103
11-Digit Billing Format
70108010301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .05 g/100mL
Usage Information
Adults and children 6 years and older:• Use daily after you brush your teeth with toothpaste.• Rinse toothpaste from mouth prior to use.• Shake well before each use.• Twist and remove cap.• Rinse or gargle for 30 seconds with 15 ml and spit out.• Do Not swallow the rinse.• Do Not eat or drink for 30 minutes after rinsing.• Supervise children as necessary.• Children under 6 years of age, consult with a dentist or doctor.

Regulatory & Marketing

Labeler Name
Ashtel Studios, Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-22-2024
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 70108-103-01 identifies a specific commercial package of 355 ml in 1 bottle, plastic of Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor, a human over the counter drug labeled by Ashtel Studios, Inc. This mouthwash 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 Ashtel Studios, Inc on September 22, 2024. The current certification is valid through December 31, 2026.

How is this Ashtel Studios, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70108010301. 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)
70108-103-01
11-Digit CMS (5-4-2)
70108-0103-01

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