Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
NDC Package 81033-512-50

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

Package Information

Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (chlorhexidine gluconate, 0.12% oral rinse) 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 Kesin Pharma Corporation, this product is identified by NDC 81033-512 and is authorized under FDA application ANDA075561.

Identification & Billing

NDC Package Code
81033-512-50
Package Description
100 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE (81033-512-15)
Product Code
81033-512
11-Digit Billing Format
81033051250
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Non-Proprietary Name
Chlorhexidine Gluconate, 0.12% Oral Rinse
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
CHLORHEXIDINE GLUCONATE 1.2 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
Kesin Pharma Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA075561
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2023
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 81033-512-50 identifies a specific commercial package of 100 cup, unit-dose in 1 carton / 15 ml in 1 cup, unit-dose (81033-512-15) of Chlorhexidine Gluconate, 0.12% Oral Rinse Solution, a human prescription drug labeled by Kesin Pharma Corporation. This solution is formulated for dental 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 Kesin Pharma Corporation on August 15, 2023. The current certification is valid through December 31, 2026.

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 Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033051250. 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)
81033-512-50
11-Digit CMS (5-4-2)
81033-0512-50

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