Urea 10% Lotion
NDC Package 87021-600-04

11-digit billing NDC: 87021060004
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Urea 10% lotions is usage: Intensely exfolitating and skin-softening cream with Urea 10%. This formulation utilizes a lotion delivery system. Marketed by Krewe Pharma, Llc, this product is identified by NDC 87021-600.

Identification & Billing

NDC Package Code
87021-600-04
Package Description
1 JAR in 1 JAR / 118 mL in 1 JAR
Product Code
87021-600
11-Digit Billing Format
87021060004

Clinical Specifications

Proprietary Name
Urea 10%
Non-Proprietary Name
Urea 10%
Substance Name
Urea
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)
UREA 100 mg/mL
Usage Information
Usage: Intensely exfolitating and skin-softening cream with Urea 10%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.

Regulatory & Marketing

Labeler Name
Krewe Pharma, Llc
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
06-02-2026
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 87021-600-04 identifies a specific commercial package of 1 jar in 1 jar / 118 ml in 1 jar of Urea 10%, a human over the counter drug labeled by Krewe Pharma, Llc. This lotion is formulated for topical use and contains urea 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 Krewe Pharma, Llc on June 02, 2026. The current certification is valid through December 31, 2027.

How is this Krewe Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87021060004. 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)
87021-600-04
11-Digit CMS (5-4-2)
87021-0600-04

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