Menthol And Zinc Oxide Ointment
NDC Package 10135-701-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Menthol And Zinc Oxide ointment is cleans with mild skin cleanserPat dry or allow to air dryApply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection. This formulation utilizes a ointment delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-701 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
10135-701-04
Package Description
113 g in 1 TUBE
Product Code
10135-701
11-Digit Billing Format
10135070104
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: 2123045 - menthol 0.44 % / zinc oxide 20.6 % Topical Ointment
  • RxCUI: 2123045 - menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment
  • RxCUI: 2123045 - Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Menthol And Zinc Oxide
Non-Proprietary Name
Menthol And Zinc Oxide
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
Cleans with mild skin cleanserPat dry or allow to air dryApply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-701-04 identifies a specific commercial package of 113 g in 1 tube of Menthol And Zinc Oxide, a human over the counter drug labeled by Marlex Pharmaceuticals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 113 billable units per package. 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 Marlex Pharmaceuticals, Inc. on May 01, 2021. The current certification is valid through December 31, 2026.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135070104. 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)
10135-701-04
11-Digit CMS (5-4-2)
10135-0701-04

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