Ipana Wintergreen Fluoride Paste
NDC Package 69510-010-19

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

Package Information

Ipana Wintergreen Fluoride (sodium monofluorophosphate) pastes is adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). This formulation utilizes a paste delivery system. Marketed by Maxill Inc., this product is identified by NDC 69510-010 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
69510-010-19
Package Description
1 TUBE in 1 BOX / 19 g in 1 TUBE
Product Code
69510-010
11-Digit Billing Format
69510001019
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Ipana Wintergreen Fluoride
Non-Proprietary Name
Sodium Monofluorophosphate
Substance Name
Sodium Monofluorophosphate
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM MONOFLUOROPHOSPHATE .1 g/100g
Usage Information
Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Maxill Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-31-2014
End Marketing Date
07-31-2029
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 69510-010-19 identifies a specific commercial package of 1 tube in 1 box / 19 g in 1 tube of Ipana Wintergreen Fluoride, a human over the counter drug labeled by Maxill Inc.. This paste is formulated for dental use and contains sodium monofluorophosphate 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 Maxill Inc. on December 31, 2014.

How is this Maxill Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69510001019. 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)
69510-010-19
11-Digit CMS (5-4-2)
69510-0010-19

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