Chlorhexidine Gluconate Cloth
NDC Package 53462-705-20

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

Package Information

Chlorhexidine Gluconate cloths 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 cloth delivery system. Marketed by Sage Products Llc, this product is identified by NDC 53462-705 and is authorized under FDA application NDA021669.

Identification & Billing

NDC Package Code
53462-705-20
Package Description
2 CLOTH in 1 PACKAGE
Product Code
53462-705
11-Digit Billing Format
53462070520
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Chlorhexidine Gluconate
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
Dosage Form
Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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 500 mg/1
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
Sage Products Llc
Product Type
Human Otc Drug
FDA Application #
NDA021669
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53462-705). Click a package code to view its specific billing and regulatory data.

53462-705-23
6 CLOTH in 1 PACKAGE
53462-705-26
6 CLOTH in 1 PACKAGE

* 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 53462-705-20 identifies a specific commercial package of 2 cloth in 1 package of Chlorhexidine Gluconate, a human over the counter drug labeled by Sage Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This cloth 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 Sage Products Llc on February 01, 2006. 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 Sage Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53462070520. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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)
53462-705-20
11-Digit CMS (5-4-2)
53462-0705-20

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