Monsels Solution Paste
NDC Package 48783-113-08

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

Package Information

Monsels Solution (ferric subsulfate) pastes is classified as a

administered via topical route. This formulation utilizes a paste delivery system. Marketed by Premier Dental Products Company, this product is identified by NDC 48783-113.

Identification & Billing

NDC Package Code
48783-113-08
Package Description
14 g in 1 VIAL, SINGLE-DOSE
Product Code
48783-113
11-Digit Billing Format
48783011308
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Monsels Solution
Non-Proprietary Name
Ferric Subsulfate
Substance Name
Ferric Subsulfate
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
FERRIC SUBSULFATE 210 mg/g
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Premier Dental Products Company
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-29-2024
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 48783-113-08 identifies a specific commercial package of 14 g in 1 vial, single-dose of Monsels Solution, a human prescription drug labeled by Premier Dental Products Company. This paste is formulated for topical use and contains ferric subsulfate 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 Premier Dental Products Company on November 29, 2024. The current certification is valid through December 31, 2027.

How is this Premier Dental Products Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48783011308. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
48783-113-08
11-Digit CMS (5-4-2)
48783-0113-08

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