Act Anticavity Fluoride Kids Wild Watermelon Paste
NDC Package 41167-0924-2

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

Package Information

Act Anticavity Fluoride Kids Wild Watermelon (sodium fluoride 0.24 (0.14 w/v fluoride ion)) pastes is adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctorchildren 2 to 6 years of ageinstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). This formulation utilizes a paste delivery system. Marketed by Chattem, Inc., this product is identified by NDC 41167-0924 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
41167-0924-2
Package Description
130 g in 1 TUBE
Product Code
41167-0924
11-Digit Billing Format
41167092402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Act Anticavity Fluoride Kids Wild Watermelon
Non-Proprietary Name
Sodium Fluoride 0.24 (0.14 W/v Fluoride Ion)
Substance Name
Sodium Fluoride
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SODIUM FLUORIDE 1.4 mg/g
Usage Information
Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctorchildren 2 to 6 years of ageinstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.children under 2 years of agedo not use unless directed by a dentist or doctor

Regulatory & Marketing

Labeler Name
Chattem, Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-21-2019
Listing Expiration
12-31-2027
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 41167-0924-2 identifies a specific commercial package of 130 g in 1 tube of Act Anticavity Fluoride Kids Wild Watermelon, a human over the counter drug labeled by Chattem, Inc.. This paste is formulated for topical 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 Chattem, Inc. on May 21, 2019. The current certification is valid through December 31, 2027.

How is this Chattem, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41167092402. 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 (5-4-1)
41167-0924-2
11-Digit CMS (5-4-2)
41167-0924-02

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