Remedy Calazime Skin Protectant Paste
NDC Package 53329-165-44

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

Remedy Calazime Skin Protectant (calamine, menthol, white petrolatum, zinc oxide) pastes is adultsCleanse the affected area with Remedy No-rinse cleanserGently dryApply externally to the affected area up to 6 times dailyFor peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed.Children under 12 years of ageConsult a doctor. This formulation utilizes a paste delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-165 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
53329-165-44
Package Description
113 g in 1 TUBE
Product Code
53329-165
11-Digit Billing Format
53329016544
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
113 GM
RxNorm Crosswalk
  • RxCUI: 1921772 - calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste
  • RxCUI: 1921772 - calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste
  • RxCUI: 1921772 - Calamine 0.035 MG/MG / Menthol 0.002 MG/MG / Petrolatum 0.69 MG/MG / ZNO 0.165 MG/MG Paste

Clinical Specifications

Proprietary Name
Remedy Calazime Skin Protectant
Non-Proprietary Name
Calamine, Menthol, White Petrolatum, Zinc Oxide
Substance Name
Ferric Oxide Red; Menthol; Petrolatum; Zinc Oxide
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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
AdultsCleanse the affected area with Remedy No-rinse cleanserGently dryApply externally to the affected area up to 6 times dailyFor peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed.Children under 12 years of ageConsult a doctor

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-23-2012
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 (53329-165). Click a package code to view its specific billing and regulatory data.

53329-165-02
3 TUBE in 1 BAG / 113 g in 1 TUBE (53329-165-44)
53329-165-96
144 PACKET in 1 BOX / 4 g in 1 PACKET

* 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 53329-165-44 identifies a specific commercial package of 113 g in 1 tube of Remedy Calazime Skin Protectant, a human over the counter drug labeled by Medline Industries, Lp. This product is billed per "GM" gram and contains an estimated amount of 113 billable units per package. This paste is formulated for topical use and contains ferric oxide red; menthol; petrolatum; 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 Medline Industries, Lp on March 23, 2012. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329016544. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 113 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)
53329-165-44
11-Digit CMS (5-4-2)
53329-0165-44

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