Charm-tex Fluoride Gel
NDC Package 77573-012-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Charm-tex Fluoride Gel is adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowingChildren under 2 years: Ask a dentist or physician. Marketed by Jiangsu Aimeili Cosmetic Co.,ltd., this product is identified by NDC 77573-012 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
77573-012-07
Package Description
60 TUBE in 1 PACKAGE / 181 g in 1 TUBE
Product Code
11-Digit Billing Format
77573001207
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Charm-tex Fluoride Gel
Dosage Form
-
Usage Information
Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowingChildren under 2 years: Ask a dentist or physician

Regulatory & Marketing

Labeler Name
Jiangsu Aimeili Cosmetic Co.,ltd.
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-10-2022
Listing Expiration
12-31-2025
Exclude Flag
I
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 (77573-012). Click a package code to view its specific billing and regulatory data.

1000 TUBE in 1 PACKAGE / 7.1 g in 1 TUBE
720 TUBE in 1 PACKAGE / 17 g in 1 TUBE
720 TUBE in 1 PACKAGE / 24 g in 1 TUBE
144 TUBE in 1 PACKAGE / 43 g in 1 TUBE
144 TUBE in 1 PACKAGE / 78 g in 1 TUBE
60 TUBE in 1 PACKAGE / 130 g in 1 TUBE

* 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 77573-012-07 identifies a specific commercial package of 60 tube in 1 package / 181 g in 1 tube of Charm-tex Fluoride Gel, labeled by Jiangsu Aimeili Cosmetic Co.,ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Jiangsu Aimeili Cosmetic Co.,ltd. on July 10, 2022. The current certification is valid through December 31, 2025.

How is this Jiangsu Aimeili Cosmetic Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77573001207. 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)
77573-012-07
11-Digit CMS (5-4-2)
77573-0012-07

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