Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% Solution
NDC Package 0404-0221-04

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

Package Information

Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (chlorhexidine gluconate) solution is a medication used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. This formulation utilizes a solution delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-0221 and is authorized under FDA application NDA019258.

Identification & Billing

NDC Package Code
0404-0221-04
Package Description
473 mL in 1 BOTTLE
Product Code
0404-0221
11-Digit Billing Format
00404022104
RxNorm Crosswalk
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub
  • RxCUI: 2630838 - Maxiclens 4 % Medicated Liquid Soap
  • RxCUI: 2630838 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap [Maxiclens]

Clinical Specifications

Proprietary Name
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
CHLORHEXIDINE GLUCONATE 40 mg/mL
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
Usage Information
This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Otc Drug
FDA Application #
NDA019258
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-17-2021
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 0404-0221-04 identifies a specific commercial package of 473 ml in 1 bottle of Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%, a human over the counter drug labeled by Henry Schein, Inc.. This solution is formulated for topical use and contains chlorhexidine gluconate 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 Henry Schein, Inc. on November 17, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404022104. 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 (4-4-2)
0404-0221-04
11-Digit CMS (5-4-2)
00404-0221-04

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