Decure Paste, Dentifrice
NDC Package 84132-100-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Decure (sodium monofluorophosphate) pastes is not recommended for infants. This formulation utilizes a paste, dentifrice delivery system. Marketed by Scope Medical Devices Private Limited, this product is identified by NDC 84132-100 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
84132-100-10
Package Description
10 g in 1 TUBE
Product Code
84132-100
11-Digit Billing Format
84132010010
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
Decure
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 7.6 mg/g
Usage Information
Not recommended for infants. Wet hands thoroughly with product & allow to self dry. Children under 6 years of age should be supervised when using this product . Adults & 6+ ChildrenBrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physicianChildren under 6 yrs.To minimize swallowing use a pea - sized amount and supervise brushing.Children under 2 yrs.Ask a dentist or physician.NDC NO. 84132-100-10

Regulatory & Marketing

Labeler Name
Scope Medical Devices Private Limited
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-11-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84132-100-10 identifies a specific commercial package of 10 g in 1 tube of Decure, a human over the counter drug labeled by Scope Medical Devices Private Limited. 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 Scope Medical Devices Private Limited on May 11, 2024. The current certification is valid through December 31, 2026.

How is this Scope Medical Devices Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84132010010. 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)
84132-100-10
11-Digit CMS (5-4-2)
84132-0100-10

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