Hydro Gyn Gel
NDC Package 85964-001-01

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

Package Information

Hydro Gyn (calendula offcianalis, olive extract) gel is preparation:Place a sanitary panty liner in your underwear to prevent any potential leakage. This formulation utilizes a gel delivery system. Marketed by Shenzhen Water Element E-commerce Co., Ltd, this product is identified by NDC 85964-001.

Identification & Billing

NDC Package Code
85964-001-01
Package Description
10 BAG in 1 BOX / 10 mL in 1 BAG
Product Code
85964-001
11-Digit Billing Format
85964000101

Clinical Specifications

Proprietary Name
Hydro Gyn
Non-Proprietary Name
Calendula Offcianalis, Olive Extract
Substance Name
Calendula Officinalis Flowering Top; Oleuropein
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Usage Information
Preparation:Place a sanitary panty liner in your underwear to prevent any potential leakage. Carefully open the sealed foil pouch and remove the pre - filled applicator. Do not tamper with the applicator tip until ready for use. Positioning:Recline in a comfortable position on your back with your knees bent to facilitate insertion. Alternatively, you may stand or sit, based on your preference and comfort. Application:Gently insert the thin end of the applicator into the vaginal opening until comfortable. Firmly press the thick end of the applicator to dispense the product completely into the vaginal canal. Post - Application:Remove and discard the applicator immediately after use. Do not attempt to reuse. Be aware that a slight increase in vaginal burning, itching, or irritation may occur temporarily as your body adjusts to the product. If these symptoms persist or worsen, consult a healthcare provider. Ensure to follow these instructions carefully for optimal results and safety.

Regulatory & Marketing

Labeler Name
Shenzhen Water Element E-commerce Co., Ltd
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-08-2025
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 85964-001-01 identifies a specific commercial package of 10 bag in 1 box / 10 ml in 1 bag of Hydro Gyn, a human over the counter drug labeled by Shenzhen Water Element E-commerce Co., Ltd. This gel is formulated for cutaneous use and contains calendula officinalis flowering top; oleuropein 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 Shenzhen Water Element E-commerce Co., Ltd on August 08, 2025. The current certification is valid through December 31, 2026.

How is this Shenzhen Water Element E-commerce Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85964000101. 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)
85964-001-01
11-Digit CMS (5-4-2)
85964-0001-01

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