Glister Multi-action Paste, Dentifrice
NDC Package 10056-415-01

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

Glister Multi-action (sodium fluoride) pastes is • 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 or doctor.• 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 doctor. This formulation utilizes a paste, dentifrice delivery system. Marketed by Access Business Group Llc, this product is identified by NDC 10056-415 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
10056-415-01
Package Description
1 TUBE in 1 CARTON / 200 g in 1 TUBE
Product Code
10056-415
11-Digit Billing Format
10056041501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glister Multi-action
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.
Active Ingredient(s)
SODIUM FLUORIDE 2.1 mg/g
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 or doctor.• 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 doctor.

Regulatory & Marketing

Labeler Name
Access Business Group Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-22-2023
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 (10056-415). Click a package code to view its specific billing and regulatory data.

10056-415-00
1 TUBE in 1 CARTON / 50 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 10056-415-01 identifies a specific commercial package of 1 tube in 1 carton / 200 g in 1 tube of Glister Multi-action, a human over the counter drug labeled by Access Business Group Llc. 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 Access Business Group Llc on March 22, 2023. The current certification is valid through December 31, 2026.

How is this Access Business Group Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10056041501. 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)
10056-415-01
11-Digit CMS (5-4-2)
10056-0415-01

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