Zinc Oxide 20% Ointment
NDC Package 69396-021-54

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

Zinc Oxide 20% (zinc oxide) ointment is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a ointment delivery system. Marketed by Trifecta Pharmaceuticals Usa, this product is identified by NDC 69396-021 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
69396-021-54
Package Description
1 JAR in 1 JAR / 454 g in 1 JAR
Product Code
69396-021
11-Digit Billing Format
69396002154
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
454 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zinc Oxide 20%
Non-Proprietary Name
Zinc Oxide
Substance Name
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.
  • 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
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceuticals Usa
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-26-2018
Listing Expiration
12-31-2027
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 (69396-021). Click a package code to view its specific billing and regulatory data.

69396-021-01
1 TUBE in 1 BOX / 28 g in 1 TUBE
69396-021-02
1 TUBE in 1 BOX / 60 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 69396-021-54 identifies a specific commercial package of 1 jar in 1 jar / 454 g in 1 jar of Zinc Oxide 20%, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa. This product is billed per "GM" gram and contains an estimated amount of 454 billable units per package. This ointment is formulated for topical use and contains 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 Trifecta Pharmaceuticals Usa on January 26, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Trifecta Pharmaceuticals Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396002154. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 454 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)
69396-021-54
11-Digit CMS (5-4-2)
69396-0021-54

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