NDC Package 53329-083-21 Sparklefresh Flouride Toothpaste

Sodium Monofluorophosphate Paste, Dentifrice Dental - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

53329-083-21

Package Description:

42.5 g in 1 TUBE

Product Code:

53329-083

Proprietary Name:

Sparklefresh Flouride Toothpaste

Non-Proprietary Name:

Sodium Monofluorophosphate

Substance Name:

Sodium Monofluorophosphate

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.

11-Digit NDC Billing Format:

53329008321

NDC to 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

Product Type:

Human Otc Drug

Labeler Name:

Medline Industries, Lp

Dosage Form:

Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

Administration Route(s):

Dental - Administration to a tooth or teeth.

Active Ingredient(s):

SODIUM MONOFLUOROPHOSPHATE 1 mg/g

Sample Package:

FDA Application Number:

part355

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

01-01-2007

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

53329 - Medline Industries, Lp
- 53329-083 - Sparklefresh
  - 53329-083-21 - 42.5 g in 1 TUBE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
53329-083-92	17 g in 1 PACKET
53329-083-93	24 g in 1 PACKET
53329-083-94	78 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 53329-083-21?

The NDC Packaged Code 53329-083-21 is assigned to a package of 42.5 g in 1 tube of Sparklefresh Flouride Toothpaste, a human over the counter drug labeled by Medline Industries, Lp. The product's dosage form is paste, dentifrice and is administered via dental form.

Is NDC 53329-083 included in the NDC Directory?

Yes, Sparklefresh Flouride Toothpaste with product code 53329-083 is active and included in the NDC Directory. The product was first marketed by Medline Industries, Lp on January 01, 2007 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53329-083-21?

The 11-digit format is 53329008321. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	53329-083-21	5-4-2	53329-0083-21

Table of Contents