D-col Personal Hygiene Convenience Kit
NDC Package 53205-001-01

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

Package Information

D-col Personal Hygiene Convenience Kit (pyrithione zinc and chloroxylenol) kits is patient antiseptic skin preparation. This formulation utilizes a kit delivery system. Marketed by D-col Inc, this product is identified by NDC 53205-001 and is authorized under FDA application M032.

Identification & Billing

NDC Package Code
53205-001-01
Package Description
1 KIT in 1 CARTON * 15 mL in 1 PACKET * 1 mL in 1 PACKET * 7.4 mL in 1 PACKET
Product Code
53205-001
11-Digit Billing Format
53205000101

Clinical Specifications

Proprietary Name
D-col Personal Hygiene Convenience Kit
Non-Proprietary Name
Pyrithione Zinc And Chloroxylenol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Patient antiseptic skin preparation. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin area and wash gently. Rinse thoroughly with water. Surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL of the product with a brush. Rinse thoroughly under running water.Healthcare personnel handwash. Wet hands with water. Dispense about 5 mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly. Apply a reasonable amount of the product to the end of your index finger for a single nasal inner rim application.Save a reasonable amount to apply to the opposite nasal inner rim.Insert your index finger into one nostril no further than the inner rim, and cover the inner rim of the nasal passage with the product.Do not apply the product beyond the inner rim of the nasal passage.Repeat the application of the product to the untreated nasal inner rim.Wait 30 seconds after you complete the application, and thoroughly wipe the inner rim of each nostril with a cloth wet with water.Children under 6 years of age should be supervised when using this product. Place enough product in your palm to thoroughly cover the scalp area.Rub hands together until product covers entire surface of your palms.Apply product to the scalp and thoroughly massage and cover the scalp.Rinse with water until the product is completely removed from the application area.Use one packet as directed.Children under 6 years of age should be supervised when using this product.

Regulatory & Marketing

Labeler Name
D-col Inc
Product Type
Human Otc Drug
FDA Application #
M032
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-30-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53205-001-01 identifies a specific commercial package of 1 kit in 1 carton * 15 ml in 1 packet * 1 ml in 1 packet * 7.4 ml in 1 packet of D-col Personal Hygiene Convenience Kit, a human over the counter drug labeled by D-col Inc. This kit is formulated for use and contains 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 D-col Inc on May 30, 2018. The current certification is valid through December 31, 2026.

How is this D-col Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53205000101. 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)
53205-001-01
11-Digit CMS (5-4-2)
53205-0001-01

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