Finipil Lait 50 Cream
NDC Package 53228-050-01

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

Package Information

Finipil Lait 50 (benzethonium chloride) cream is directionsApply a small amount of this product on the area daily. This formulation utilizes a cream delivery system. Marketed by Equibal, Inc., this product is identified by NDC 53228-050 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
53228-050-01
Package Description
44 mL in 1 TUBE
Product Code
53228-050
11-Digit Billing Format
53228005001

Clinical Specifications

Proprietary Name
Finipil Lait 50
Non-Proprietary Name
Benzethonium Chloride
Substance Name
Benzethonium Chloride
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the 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)
BENZETHONIUM CHLORIDE 195 mg/100mL
Usage Information
DirectionsApply a small amount of this product on the area daily.

Regulatory & Marketing

Labeler Name
Equibal, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2013
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 53228-050-01 identifies a specific commercial package of 44 ml in 1 tube of Finipil Lait 50, a human over the counter drug labeled by Equibal, Inc.. This cream is formulated for topical use and contains benzethonium chloride 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 Equibal, Inc. on March 01, 2013. The current certification is valid through December 31, 2026.

How is this Equibal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53228005001. 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)
53228-050-01
11-Digit CMS (5-4-2)
53228-0050-01

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