1. Home
  2. Labeler Index
  3. Medline Industries, Lp
  4. 53329-165
  5. NDC Package Code: 53329-165-02 Remedy Calazime Skin Protectant

NDC Package 53329-165-02 Remedy Calazime Skin Protectant

Calamine,Menthol,White Petrolatum,Zinc Oxide Paste Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
53329-165-02
Package Description:
3 TUBE in 1 BAG / 113 g in 1 TUBE (53329-165-44)
Product Code:
53329-165
Proprietary Name:
Remedy Calazime Skin Protectant
Non-Proprietary Name:
Calamine, Menthol, White Petrolatum, Zinc Oxide
Substance Name:
Ferric Oxide Red; Menthol; Petrolatum; Zinc Oxide
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
11-Digit NDC Billing Format:
53329016502
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Medline Industries, Lp
    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(s):
  • 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):
  • FERRIC OXIDE RED .5 g/100g
  • MENTHOL .2 g/100g
  • PETROLATUM 69 g/100g
  • ZINC OXIDE 19.5 g/100g
    • Sample Package:
    No
    FDA Application Number:
    part347
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    03-23-2012
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53329-165-02?

    The NDC Packaged Code 53329-165-02 is assigned to a package of 3 tube in 1 bag / 113 g in 1 tube (53329-165-44) of Remedy Calazime Skin Protectant, a human over the counter drug labeled by Medline Industries, Lp. The product's dosage form is paste and is administered via topical form.

    Is NDC 53329-165 included in the NDC Directory?

    Yes, Remedy Calazime Skin Protectant with product code 53329-165 is active and included in the NDC Directory. The product was first marketed by Medline Industries, Lp on March 23, 2012 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 53329-165-02?

    The 11-digit format is 53329016502. 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
    5-3-253329-165-025-4-253329-0165-02