Willo Bubble Twist Paste, Dentifrice
NDC Package 84185-102-08

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

Willo Bubble Twist (sodium fluoride) pastes is adults andchildren 2 yearsof age and olderbrush teeth thoroughly, preferablyafter each meal or at least twice aday, or as directed by a dentist ordoctorchildren under 6years of ageinstruct in good brushing andrinsing habits (to minimize swallowing). This formulation utilizes a paste, dentifrice delivery system. Marketed by Willo 32 Inc, this product is identified by NDC 84185-102 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84185-102-08
Package Description
237 mL in 1 BOTTLE, DISPENSING
Product Code
84185-102
11-Digit Billing Format
84185010208
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Willo Bubble Twist
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 1 mg/mL
Usage Information
Adults andchildren 2 yearsof age and olderbrush teeth thoroughly, preferablyafter each meal or at least twice aday, or as directed by a dentist ordoctorchildren under 6years of ageinstruct in good brushing andrinsing habits (to minimize swallowing). Supervise asnecessary until capable of usingwithout supervisionchildren under 2years of ageconsult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Willo 32 Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-10-2025
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 (84185-102). Click a package code to view its specific billing and regulatory data.

84185-102-22
2 BOTTLE, PUMP in 1 BOX / 59 mL in 1 BOTTLE, PUMP (84185-102-02)

* 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 84185-102-08 identifies a specific commercial package of 237 ml in 1 bottle, dispensing of Willo Bubble Twist, a human over the counter drug labeled by Willo 32 Inc. This paste, dentifrice 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 Willo 32 Inc on September 10, 2025. The current certification is valid through December 31, 2026.

How is this Willo 32 Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84185010208. 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)
84185-102-08
11-Digit CMS (5-4-2)
84185-0102-08

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