Dermatitis Face Balm Ointment
NDC Package 61328-121-12

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

Package Information

Dermatitis Face Balm (colloidal oatmeal) ointment is apply to affected areas as needed. This formulation utilizes a ointment delivery system. Marketed by Skinfix, Inc., this product is identified by NDC 61328-121 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
61328-121-12
Package Description
13.5 g in 1 TUBE
Product Code
61328-121
11-Digit Billing Format
61328012112
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermatitis Face Balm
Non-Proprietary Name
Colloidal Oatmeal
Substance Name
Oatmeal
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)
OATMEAL 5 g/100g
Pharmacologic Class
Usage Information
Apply to affected areas as needed.

Regulatory & Marketing

Labeler Name
Skinfix, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-03-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61328-121-12 identifies a specific commercial package of 13.5 g in 1 tube of Dermatitis Face Balm, a human over the counter drug labeled by Skinfix, Inc.. This ointment is formulated for topical use and contains oatmeal 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 Skinfix, Inc. on February 03, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61328012112. 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)
61328-121-12
11-Digit CMS (5-4-2)
61328-0121-12

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