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

Pyrithione Zinc And Chloroxylenol Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
Proprietary Name:
D-col Personal Hygiene Convenience Kit
Non-Proprietary Name:
Pyrithione Zinc And Chloroxylenol
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.
11-Digit NDC Billing Format:
53205000101
Product Type:
Human Otc Drug
Labeler Name:
D-col Inc
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
part358H
Marketing Category:
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date:
05-30-2018
Listing Expiration Date:
12-31-2024
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 53205-001-01?

The NDC Packaged Code 53205-001-01 is assigned to a 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. The product's dosage form is kit and is administered via form.

Is NDC 53205-001 included in the NDC Directory?

Yes, D-col Personal Hygiene Convenience Kit with product code 53205-001 is active and included in the NDC Directory. The product was first marketed by D-col Inc on May 30, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53205-001-01?

The 11-digit format is 53205000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-253205-001-015-4-253205-0001-01