Estriol 5.0 Cream
NDC Package 82018-0010-4

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

Package Information

Estriol 5.0 Cream (estriol) cream is uSES:This is a topical cream that contains bio-identical estriol derived from wild yam. This formulation utilizes a cream delivery system. Marketed by Shyne Brands, this product is identified by NDC 82018-0010.

Identification & Billing

NDC Package Code
82018-0010-4
Package Description
85 g in 1 BOTTLE, PUMP
Product Code
82018-0010
11-Digit Billing Format
82018001004

Clinical Specifications

Proprietary Name
Estriol 5.0 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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
ESTRIOL 5 mg/85g
Usage Information
USES:This is a topical cream that contains bio-identical estriol derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.DIRECTIONS:Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.

Regulatory & Marketing

Labeler Name
Shyne Brands
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
06-01-2025
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 82018-0010-4 identifies a specific commercial package of 85 g in 1 bottle, pump of Estriol 5.0 Cream, a human over the counter drug labeled by Shyne Brands. This cream is formulated for transdermal 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 Shyne Brands on June 01, 2025. The current certification is valid through December 31, 2026.

How is this Shyne Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82018001004. 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 (5-4-1)
82018-0010-4
11-Digit CMS (5-4-2)
82018-0010-04

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