Eczema Care Moisturizing Lotion
NDC Package 57337-101-01

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

Package Information

Eczema Care Moisturizing (colloidal oatmeal) lotions is apply as needed. This formulation utilizes a lotion delivery system. Marketed by Rejoice International Inc., this product is identified by NDC 57337-101 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
57337-101-01
Package Description
85 mL in 1 TUBE
Product Code
57337-101
11-Digit Billing Format
57337010101

Clinical Specifications

Proprietary Name
Eczema Care Moisturizing 3 Oz.
Non-Proprietary Name
Colloidal Oatmeal
Substance Name
Oatmeal
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 10 mg/mL
Pharmacologic Class
Usage Information
Apply as needed

Regulatory & Marketing

Labeler Name
Rejoice International Inc.
Product Type
Human Otc Drug
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-08-2019
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 57337-101-01 identifies a specific commercial package of 85 ml in 1 tube of Eczema Care Moisturizing 3 Oz., a human over the counter drug labeled by Rejoice International Inc.. This lotion 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 Rejoice International Inc. on March 08, 2019. The current certification is valid through December 31, 2026.

How is this Rejoice International Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57337010101. 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)
57337-101-01
11-Digit CMS (5-4-2)
57337-0101-01

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