Sparklefresh Paste, Dentifrice
NDC Package 53329-083-92

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

Sparklefresh (sodium monofluorophosphate) pastes is adults and children 2 yrs. This formulation utilizes a paste, dentifrice delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-083 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
53329-083-92
Package Description
17 g in 1 PACKET
Product Code
53329-083
11-Digit Billing Format
53329008392
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
Sparklefresh Flouride Toothpaste
Non-Proprietary Name
Sodium Monofluorophosphate
Substance Name
Sodium Monofluorophosphate
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 MONOFLUOROPHOSPHATE 1 mg/g
Usage Information
Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician.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 of age: consult a dentist or physician.

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2007
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 (53329-083). Click a package code to view its specific billing and regulatory data.

53329-083-21
42.5 g in 1 TUBE
53329-083-93
24 g in 1 PACKET
53329-083-94
78 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 53329-083-92 identifies a specific commercial package of 17 g in 1 packet of Sparklefresh Flouride Toothpaste, a human over the counter drug labeled by Medline Industries, Lp. This paste, dentifrice 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 Medline Industries, Lp on January 01, 2007. The current certification is valid through December 31, 2026.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329008392. 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)
53329-083-92
11-Digit CMS (5-4-2)
53329-0083-92

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