Euthymol Whitening Purple Corrector Paste, Dentifrice
NDC Package 53208-563-65

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

Euthymol Whitening Purple Corrector (sodium fluoride) pastes is adults and children 2 years of age and older. This formulation utilizes a paste, dentifrice delivery system. Marketed by Lg Household & Health Care Ltd., this product is identified by NDC 53208-563 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
53208-563-65
Package Description
1 TUBE in 1 CARTON / 106 g in 1 TUBE (53208-563-63)
Product Code
53208-563
11-Digit Billing Format
53208056365
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Euthymol Whitening Purple Corrector
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
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.
  • Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.do not swallow.to minimize swallowing use a pea-sized amount in children under 6.supervise children's brushing until good habits are established.children under 2 years: ask a dentist.

Regulatory & Marketing

Labeler Name
Lg Household & Health Care Ltd.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2025
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 (53208-563). Click a package code to view its specific billing and regulatory data.

53208-563-62
2 CELLO PACK in 1 CELLO PACK / 3 TUBE in 1 CELLO PACK (53208-563-64) / 106 g in 1 TUBE (53208-563-63)

* 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 53208-563-65 identifies a specific commercial package of 1 tube in 1 carton / 106 g in 1 tube (53208-563-63) of Euthymol Whitening Purple Corrector, a human over the counter drug labeled by Lg Household & Health Care Ltd.. This paste, dentifrice is formulated for dental 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 Lg Household & Health Care Ltd. on May 01, 2025. The current certification is valid through December 31, 2026.

How is this Lg Household & Health Care Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53208056365. 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)
53208-563-65
11-Digit CMS (5-4-2)
53208-0563-65

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