Antiseptic Skin Cleanser Liquid
NDC Package 36800-401-50

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

Package Information

Antiseptic Skin Cleanser (chlorhexidine gluconate 4%) liquids 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 liquid delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-401 and is authorized under FDA application NDA019125.

Identification & Billing

NDC Package Code
36800-401-50
Package Description
237 mL in 1 BOTTLE, PLASTIC
Product Code
36800-401
11-Digit Billing Format
36800040150
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

Clinical Specifications

Proprietary Name
Antiseptic Skin Cleanser
Non-Proprietary Name
Chlorhexidine Gluconate 4%
Substance Name
Chlorhexidine Gluconate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 mg/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
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
NDA019125
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2013
End Marketing Date
02-28-2027
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 36800-401-50 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Antiseptic Skin Cleanser, a human over the counter drug labeled by Topco Associates Llc. This liquid 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 Topco Associates Llc on November 01, 2013.

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 Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800040150. 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)
36800-401-50
11-Digit CMS (5-4-2)
36800-0401-50

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