Cetaphil Eczema Soothing Moisturizer Lotion
NDC Package 0299-4128-10

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

Cetaphil Eczema Soothing Moisturizer (colloidal oatmeal) lotions is apply as needed. This formulation utilizes a lotion delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-4128 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
0299-4128-10
Package Description
473 mL in 1 BOTTLE, PUMP
Product Code
0299-4128
11-Digit Billing Format
00299412810
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetaphil Eczema Soothing Moisturizer
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 1 g/100mL
Pharmacologic Class
Usage Information
Apply as needed

Regulatory & Marketing

Labeler Name
Galderma Laboratories, L.p.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0299-4128). Click a package code to view its specific billing and regulatory data.

0299-4128-00
296 mL in 1 BOTTLE, PUMP
0299-4128-05
29 mL in 1 BOTTLE

* 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 0299-4128-10 identifies a specific commercial package of 473 ml in 1 bottle, pump of Cetaphil Eczema Soothing Moisturizer, a human over the counter drug labeled by Galderma Laboratories, L.p.. 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 Galderma Laboratories, L.p. on May 01, 2022. The current certification is valid through December 31, 2026.

How is this Galderma Laboratories, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00299412810. 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 (4-4-2)
0299-4128-10
11-Digit CMS (5-4-2)
00299-4128-10

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