Crystlcare Regeneration Plus Film, Soluble
NDC Package 87587-250-01

11-digit billing NDC: 87587025001
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Crystlcare Regeneration Plus (potassium nitrate, sodium fluoride) films is adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. This formulation utilizes a film, soluble delivery system. Marketed by Greenmark Biomedical Inc., this product is identified by NDC 87587-250 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
87587-250-01
Package Description
14 POUCH in 1 CARTON / 150 mg in 1 POUCH (87587-250-50)
Product Code
87587-250
11-Digit Billing Format
87587025001

Clinical Specifications

Proprietary Name
Crystlcare Regeneration Plus
Non-Proprietary Name
Potassium Nitrate, Sodium Fluoride
Substance Name
Potassium Nitrate; Sodium Fluoride
Dosage Form
Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. Apply dental strip onto the teeth. Allow to remain on the teeth for 3 min and then spit out residue. Do not eat or drink for 30 minutes. Instruct children under 12 years of age in the use of this product. Supervise children as necessary until capable of using without supervision. children under the age of 6: Consult a dentist.

Regulatory & Marketing

Labeler Name
Greenmark Biomedical Inc.
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-14-2026
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 87587-250-01 identifies a specific commercial package of 14 pouch in 1 carton / 150 mg in 1 pouch (87587-250-50) of Crystlcare Regeneration Plus, a human over the counter drug labeled by Greenmark Biomedical Inc.. This film, soluble is formulated for oral use and contains potassium nitrate; 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 Greenmark Biomedical Inc. on September 14, 2026. The current certification is valid through December 31, 2027.

How is this Greenmark Biomedical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87587025001. 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)
87587-250-01
11-Digit CMS (5-4-2)
87587-0250-01

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