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  5. NDC Package Code: 85964-001-01 Hydro Gyn

NDC Package 85964-001-01 Hydro Gyn

Calendula Offcianalis,Olive Extract Gel Cutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
85964-001-01
Package Description:
10 BAG in 1 BOX / 10 mL in 1 BAG
Product Code:
85964-001
Proprietary Name:
Hydro Gyn
Non-Proprietary Name:
Calendula Offcianalis, Olive Extract
Substance Name:
Calendula Officinalis Flowering Top; Oleuropein
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.
11-Digit NDC Billing Format:
85964000101
Product Type:
Human Otc Drug
Labeler Name:
Shenzhen Water Element E-commerce Co., Ltd
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(s):
Cutaneous - Administration to the skin.
Active Ingredient(s):
Sample Package:
No
Marketing Category:
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date:
08-08-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 85964-001-01?

The NDC Packaged Code 85964-001-01 is assigned to a 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. The product's dosage form is gel and is administered via cutaneous form.

Is NDC 85964-001 included in the NDC Directory?

Yes, Hydro Gyn with product code 85964-001 is active and included in the NDC Directory. The product was first marketed by Shenzhen Water Element E-commerce Co., Ltd on August 08, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85964-001-01?

The 11-digit format is 85964000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-285964-001-015-4-285964-0001-01