Putrizen 40 Urea Cream
NDC Package 84989-025-01

11-digit billing NDC: 84989002501
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Putrizen 40 Urea (glycerin) cream is use on feet, heels, elbows, knees, or other rough areas. This formulation utilizes a cream delivery system. Marketed by Shantou Ximonth Biotechnology Co., Ltd., this product is identified by NDC 84989-025 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
84989-025-01
Package Description
150 mg in 1 BOTTLE, PLASTIC
Product Code
84989-025
11-Digit Billing Format
84989002501

Clinical Specifications

Proprietary Name
Putrizen 40 Urea
Non-Proprietary Name
Glycerin
Substance Name
Butyrospermum Parkii (shea) Butter; Simmondsia Chinensis (jojoba) Seed Oil; Melaleuca Alternifolia (tea Tree) Leaf Oil
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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)
Usage Information
Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.

Regulatory & Marketing

Labeler Name
Shantou Ximonth Biotechnology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
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 84989-025-01 identifies a specific commercial package of 150 mg in 1 bottle, plastic of Putrizen 40 Urea, a human over the counter drug labeled by Shantou Ximonth Biotechnology Co., Ltd.. This cream is formulated for topical use and contains butyrospermum parkii (shea) butter; simmondsia chinensis (jojoba) seed oil; melaleuca alternifolia (tea tree) leaf oil 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 Shantou Ximonth Biotechnology Co., Ltd. on June 02, 2026. The current certification is valid through December 31, 2027.

How is this Shantou Ximonth Biotechnology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84989002501. 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)
84989-025-01
11-Digit CMS (5-4-2)
84989-0025-01

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