Soothe And Cool Protect
NDC Package 53329-004-10

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Soothe And Cool Protect is gently cleanse and dry affected areaapply liberally to affected area as needed. Marketed by Medline Industries, Inc., this product is identified by NDC 53329-004 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
53329-004-10
Package Description
71 g in 1 TUBE
Product Code
53329-004
11-Digit Billing Format
53329000410
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
71 GM
RxNorm Crosswalk
  • RxCUI: 1043549 - Petrolatum 50 % / Zinc Oxide 10 % Paste
  • RxCUI: 1043549 - petrolatum 0.5 MG/MG / zinc oxide 0.1 MG/MG Paste
  • RxCUI: 1043549 - Petrolatum 0.5 MG/MG / Zinc Oxide 0.1 MG/MG Topical Paste
  • RxCUI: 1043549 - Petrolatum 0.5 MG/MG / ZNO 0.1 MG/MG Paste
  • RxCUI: 1302176 - Soothe & Cool Skin Paste (white petrolatum 50 % / zinc oxide 10 % ) Topical Paste

Clinical Specifications

Proprietary Name
Soothe And Cool Protect
Dosage Form
-
Usage Information
Gently cleanse and dry affected areaapply liberally to affected area as needed

Regulatory & Marketing

Labeler Name
Medline Industries, Inc.
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2007
End Marketing Date
12-31-2018
Listing Expiration
12-31-2018
Exclude Flag
D
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 (53329-004). Click a package code to view its specific billing and regulatory data.

53329-004-02
71 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 53329-004-10 identifies a specific commercial package of 71 g in 1 tube of Soothe And Cool Protect, labeled by Medline Industries, Inc.. This product is billed per "GM" gram and contains an estimated amount of 71 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medline Industries, Inc. on January 01, 2007. The current certification is valid through December 31, 2018.

How is this Medline Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329000410. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 71 total billable units per package. 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)
53329-004-10
11-Digit CMS (5-4-2)
53329-0004-10

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