Estriol Cream
NDC Package 87278-010-01

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

Package Information

Estriol Cream (estriol) cream is helps maintain hormonal balance. This formulation utilizes a cream delivery system. Marketed by Guangxi Keyun E-commerce Co., Ltd., this product is identified by NDC 87278-010 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
87278-010-01
Package Description
50 mL in 1 BOTTLE
Product Code
87278-010
11-Digit Billing Format
87278001001

Clinical Specifications

Proprietary Name
Estriol Cream
Non-Proprietary Name
Estriol
Substance Name
Estriol
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
Vaginal - Administration into the vagina.
Active Ingredient(s)
ESTRIOL .002 g/mL
Usage Information
Helps maintain hormonal balance. May help ease symptoms associated with menopause.

Regulatory & Marketing

Labeler Name
Guangxi Keyun E-commerce Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-26-2026
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 87278-010-01 identifies a specific commercial package of 50 ml in 1 bottle of Estriol Cream, a human over the counter drug labeled by Guangxi Keyun E-commerce Co., Ltd.. This cream is formulated for vaginal use and contains estriol 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 Guangxi Keyun E-commerce Co., Ltd. on March 26, 2026. The current certification is valid through December 31, 2027.

How is this Guangxi Keyun E-commerce Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87278001001. 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)
87278-010-01
11-Digit CMS (5-4-2)
87278-0010-01

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