Prosacea Gel
NDC Package 52389-173-42

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

Prosacea (sulphur) gel is read all package directions and warnings before use.Use only as directed.Clean the skin thoroughly before applying this product.Cover the entire affected area with a thin layer of Prosacea Gel one to three times daily.Massage gently until absorbed into the skin.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.Intended for use by normally healthy adults only.Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. This formulation utilizes a gel delivery system. Marketed by Kobayashi Healthcare International, Inc., this product is identified by NDC 52389-173.

Identification & Billing

NDC Package Code
52389-173-42
Package Description
2 TUBE in 1 CARTON / 21 g in 1 TUBE (52389-173-01)
Product Code
52389-173
11-Digit Billing Format
52389017342

Clinical Specifications

Proprietary Name
Prosacea
Non-Proprietary Name
Sulphur
Substance Name
Sulfur
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
SULFUR 1 [hp_X]/g
Usage Information
Read all package directions and warnings before use.Use only as directed.Clean the skin thoroughly before applying this product.Cover the entire affected area with a thin layer of Prosacea Gel one to three times daily.Massage gently until absorbed into the skin.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.Intended for use by normally healthy adults only.Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Regulatory & Marketing

Labeler Name
Kobayashi Healthcare International, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
02-06-2006
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 (52389-173). Click a package code to view its specific billing and regulatory data.

52389-173-21
1 TUBE in 1 CARTON / 21 g in 1 TUBE (52389-173-01)

* 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 52389-173-42 identifies a specific commercial package of 2 tube in 1 carton / 21 g in 1 tube (52389-173-01) of Prosacea, a human over the counter drug labeled by Kobayashi Healthcare International, Inc.. This gel is formulated for topical use and contains sulfur 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 Kobayashi Healthcare International, Inc. on February 06, 2006. The current certification is valid through December 31, 2026.

How is this Kobayashi Healthcare International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52389017342. 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)
52389-173-42
11-Digit CMS (5-4-2)
52389-0173-42

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