Sponge With 4% W/w Chlorhexidine Gluconate (chg) Sponge
NDC Package 84128-013-01

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

Package Information

Sponge With 4% W/w Chlorhexidine Gluconate (chg) (chlorhexidine gluconate) sponges 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 sponge delivery system. Marketed by Xinxiang Xinda Technology Co.,ltd, this product is identified by NDC 84128-013 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
84128-013-01
Package Description
40 BAG in 1 BOX / 1 APPLICATOR in 1 BAG / 20 mL in 1 APPLICATOR
Product Code
84128-013
11-Digit Billing Format
84128001301

Clinical Specifications

Proprietary Name
Sponge With 4% W/w Chlorhexidine Gluconate (chg)
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
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
Xinxiang Xinda Technology Co.,ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-27-2024
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 84128-013-01 identifies a specific commercial package of 40 bag in 1 box / 1 applicator in 1 bag / 20 ml in 1 applicator of Sponge With 4% W/w Chlorhexidine Gluconate (chg), a human over the counter drug labeled by Xinxiang Xinda Technology Co.,ltd. This sponge 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 Xinxiang Xinda Technology Co.,ltd on February 27, 2024. 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 Xinxiang Xinda Technology Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84128001301. 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)
84128-013-01
11-Digit CMS (5-4-2)
84128-0013-01

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