Hydro Gyn Gel
NDC 85964-001

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 85964-001?
  4. Hydro Gyn Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Hydro Gyn (calendula offcianalis, olive extract) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Shenzhen Water Element E-commerce Co., Ltd. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gel for cutaneous administration. This product entry covers the primary NDC 85964-001 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85964-001
Proprietary Name:
Hydro Gyn
Non-Proprietary Name: [1]
Calendula Offcianalis, Olive Extract
Substance Name: [2]
Calendula Officinalis Flowering Top; Oleuropein
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Cutaneous - Administration to the skin.

Labeler & Regulatory Data

Labeler Name: [5]
Shenzhen Water Element E-commerce Co., Ltd
Labeler Code:
85964
Product Label ID:
3bd3a52d-eaff-1c9f-e063-6394a90abbb6
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
08-08-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 85964-001?

The NDC code 85964-001 is assigned by the FDA to the product Hydro Gyn. It is commonly known by its generic name, calendula offcianalis, olive extract. This pharmaceutical product is labeled by Shenzhen Water Element E-commerce Co., Ltd and is currently categorized as listed product. The medication is a gel administered via cutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 85964-001-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)
  • OLEUROPEIN (UNII: 2O4553545L)
  • OLEUROPEIN (UNII: 2O4553545L) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".