Chlorhexidine Gluconate Gel
NDC Package 68599-5400-3

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Chlorhexidine Gluconate (antiseptic skin cleanser) gel 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 gel delivery system. Marketed by Mckesson, this product is identified by NDC 68599-5400 and is authorized under FDA application NDA019125.

Identification & Billing

NDC Package Code
68599-5400-3
Package Description
10 BOX in 1 CASE / 50 PACKET in 1 BOX (68599-5400-2) / 15 mL in 1 PACKET (68599-5400-1)
Product Code
68599-5400
11-Digit Billing Format
68599540003

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate
Non-Proprietary Name
Antiseptic Skin Cleanser
Substance Name
Chlorhexidine Gluconate
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 4 g/100mL
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
Mckesson
Product Type
Human Otc Drug
FDA Application #
NDA019125
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-12-2018
End Marketing Date
07-31-2026
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 68599-5400-3 identifies a specific commercial package of 10 box in 1 case / 50 packet in 1 box (68599-5400-2) / 15 ml in 1 packet (68599-5400-1) of Chlorhexidine Gluconate, a human over the counter drug labeled by Mckesson. This gel 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 Mckesson on March 12, 2018.

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 Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68599540003. 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 (5-4-1)
68599-5400-3
11-Digit CMS (5-4-2)
68599-5400-03

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