Soft And Silky Antiseptic Solution
NDC Package 50865-025-12

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

Soft And Silky Antiseptic (antiseptic lotion soap) solution is handwash to help decrease bacteria on the skin.USDA E-1Do not use in the eyes. This formulation utilizes a solution delivery system. Marketed by Kutol Products Company, Inc., this product is identified by NDC 50865-025 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
50865-025-12
Package Description
1200 mL in 1 BAG
Product Code
50865-025
11-Digit Billing Format
50865002512

Clinical Specifications

Proprietary Name
Soft And Silky Antiseptic
Non-Proprietary Name
Antiseptic Lotion Soap
Substance Name
Chloroxylenol
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
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)
CHLOROXYLENOL 3.82 g/100mL
Usage Information
Handwash to help decrease bacteria on the skin.USDA E-1Do not use in the eyes. In case of contact, immediately flush with water.Stop use and ask a doctor if irritation or redness appears and lasts.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Regulatory & Marketing

Labeler Name
Kutol Products Company, Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-04-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50865-025). Click a package code to view its specific billing and regulatory data.

50865-025-03
208175 mL in 1 DRUM
50865-025-07
3785 mL in 1 BOTTLE, PLASTIC
50865-025-09
3785 mL in 1 BOTTLE, PLASTIC
50865-025-18
500 mL in 1 BAG
50865-025-65
800 mL in 1 BAG
50865-025-80
800 mL in 1 BOTTLE, PLASTIC
50865-025-82
800 mL in 1 BOTTLE, PLASTIC
50865-025-93
1200 mL in 1 BOTTLE, PLASTIC

* 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 50865-025-12 identifies a specific commercial package of 1200 ml in 1 bag of Soft And Silky Antiseptic, a human over the counter drug labeled by Kutol Products Company, Inc.. This solution is formulated for topical use and contains chloroxylenol 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 Kutol Products Company, Inc. on November 04, 2013. The current certification is valid through December 31, 2026.

How is this Kutol Products Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50865002512. 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)
50865-025-12
11-Digit CMS (5-4-2)
50865-0025-12

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