Barrier Protectant Cream Ointment
NDC Package 63517-003-34

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

Barrier Protectant Cream (barrier cream) ointment is gently cleanse and remove any urine or fecal matter from the treatment areaPat dryApply a generous amount of product to the affected areaRepeat after every incontinent episode or as neededFor peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed. This formulation utilizes a ointment delivery system. Marketed by Cardinal Health, this product is identified by NDC 63517-003 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
63517-003-34
Package Description
150 POUCH in 1 BOX / 5 g in 1 POUCH
Product Code
63517-003
11-Digit Billing Format
63517000334

Clinical Specifications

Proprietary Name
Barrier Protectant Cream
Non-Proprietary Name
Barrier Cream
Substance Name
Menthol; Zinc Oxide
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
Usage Information
Gently cleanse and remove any urine or fecal matter from the treatment areaPat dryApply a generous amount of product to the affected areaRepeat after every incontinent episode or as neededFor peri-G tubes: •Cleanse as above  •Apply thin layer  •Secure with drain sponge or product as directed.

Regulatory & Marketing

Labeler Name
Cardinal Health
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-15-2015
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 (63517-003). Click a package code to view its specific billing and regulatory data.

63517-003-31
113 g in 1 TUBE
63517-003-32
57 g in 1 TUBE

* 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 63517-003-34 identifies a specific commercial package of 150 pouch in 1 box / 5 g in 1 pouch of Barrier Protectant Cream, a human over the counter drug labeled by Cardinal Health. This ointment is formulated for topical use and contains menthol; zinc oxide 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 Cardinal Health on January 15, 2015. The current certification is valid through December 31, 2026.

How is this Cardinal Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63517000334. 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)
63517-003-34
11-Digit CMS (5-4-2)
63517-0003-34

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