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Hydro Gyn Calendula Offcianalis, Olive Extract 3 [hp_X]/mL; 3 [hp_X]/mL Gel

by Shenzhen water element e-commerce Co., LTD · 10 BAG in 1 BOX (85964-001-01) / 10 mL in 1 BAG
NDC 85964-0001-01
🏷️ FDA NDC (as labeled) 85964-001-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 85964-001-01
Product NDC 85964-001
11-digit billing NDC 85964000101
UNII 18E7415PXQ, 2O4553545L
SPL Set ID 3bd3a52d-eaff-1c9f-e063-6394a90abbb6
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-08-08
Route CUTANEOUS
Dosage form GEL
Substance CALENDULA OFFICINALIS FLOWERING TOP; OLEUROPEIN
Why two NDCs? The FDA registers this code as 85964-001-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85964-0001-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerShenzhen water element e-commerce Co., LTD
Labeler code85964
First marketedAug 2025
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Hydro Gyn Calendula Officinalis, Olive Extract is a gel product applied directly to the skin that contains calendula flowering top and oleuropein (an olive extract component). In homeopathic practice, calendula is traditionally used for skin-related concerns, while olive extract components are included in various topical products. This is an unapproved homeopathic product, meaning it is marketed based on homeopathic tradition and has not been evaluated by the FDA for effectiveness.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII V1IA3S3CUS
    A plant extract derived from Cnidium monnieri fruit, commonly used in traditional Asian medicine preparations. In formulations, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product type.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII 01G73H6H83
    A plant extract from hop flowers, commonly used in brewing. In medicines, hops may serve as a flavoring agent or natural preservative to help maintain product stability.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4E8QL88U6H
    Taraxacum mongolicum whole is a dried plant material from the dandelion family. It's included as a filler and natural ingredient to add bulk and volume to the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPurified water, Hyaluronic Acid 0.05%, Tocopherol Acetate (Vitamin E), Carbomer, Carbomer, Sodium Hyaluron Hydroxide, Sodium Edetate, Hop extract, Organic Olive Oil, Organic Avocado Oil, Olive Fruit Vilin Extract, Taraxacum Mongolicum Extract

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydro Gyn 3 [hp_X]/mL; 3 [hp_X]/mLthis 85964-0001-01 Shenzhen 10 ml — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85964-0001-01 You're viewing this 10 BAG in 1 BOX (85964-001-01) / 10 mL in 1 BAG 2025-08-08 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing No longer marketed (per FDA listing data)

About homeopathic listings

Hydro Gyn Calendula Offcianalis, Olive Extract 3 [hp_X]/mL; 3 [hp_X]/mL GEL is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 85964-001-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85964-0001-01, written without dashes as 85964000101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85964-0001-01, the first segment (85964) is the labeler code FDA assigned to Shenzhen water element e-commerce Co., LTD; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Shenzhen water element e-commerce Co., LTD is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 99 words ▾

Uses HydroGYN Vaginal Moisturizer is formulated to address symptoms associated with estrogen deficiency during menopause, perimenopause, or other vaginal changes that contribute to vaginal atrophy. It is specifically designed to provide relief from vaginal dryness, irritation, and discomfort caused by thinning and inflammation of the vaginal walls (atrophic vaginitis). By restoring and maintaining optimal vaginal moisture levels, this product helps support the natural vaginal microbiome and may assist in reducing the risk of urinary tract infections associated with vaginal atrophy.

It is also suitable for managing symptoms related to menopause, perimenopause, postpartum recovery, or conditions requiring enhanced vaginal hydration.

⏱️ Dosage and Administration 158 words ▾

Directions 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.

⚠️ Warnings ~1 min read ▾

Warnings • For vaginal use only. • Do not use this product if you have a known allergy to any of its ingredients. • Consult your healthcare provider before use if you are pregnant, breastfeeding, or undergoing treatment for a vaginal infection. • Do not use this product if the seal is broken or missing. • In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. When using this product • Administer only as directed. Avoid exceeding the recommended application frequency. • To prevent potential desensitization or tolerance, do not use the product more than once within a 48 - hour period unless otherwise advised by a healthcare professional. • Before using this product with other therapeutic products such as douches, spermicides, or antifungal treatments, seek medical guidance to avoid interactions or diminished therapeutic efficacy. • Mild vaginal sensations, including burning, itching, or irritation, may occur initially.

Should these symptoms persist, intensify, or be accompanied by abnormal discharge, bleeding, or systemic symptoms (e.g., fever, chills), discontinue use and consult a healthcare provider promptly. • Do not reuse or share the applicator to minimize the risk of contamination or infection. Dispose of the applicator after a single use. Stop Use and Consult a Healthcare Provider If • Symptoms do not improve after 3 applications or worsen during use. • You experience severe vaginal irritation, abnormal discharge, or unexpected bleeding. • Systemic symptoms such as fever, chills, or abdominal pain occur. • Premenopausal women experience any of the above - mentioned symptoms.

If Pregnant or Breastfeeding Consult a healthcare provider before using this product to ensure its safety and suitability during pregnancy or lactation. keep out of reach of children This product is intended for adult use only. In case of accidental ingestion by a child, seek immediate medical attention or contact a Poison Control Center.

📦 Storage and Handling 91 words ▾

Other information • Do not use this product if the sealed packaging is compromised, damaged, or previously opened. • Store at a controlled temperature of 20°C to 25°C (68°F to 77°F). • Protect the product from direct sunlight as excessive ultraviolet (UV) rays may degrade the product stability. • Temporary deviations outside this range are acceptable but should be minimized to preserve product and effectiveness of the homeopathic ingredients. • If the product is frozen, thaw it before use. • Always store the product in a dark, cool, and dry location.

🧪 Active Ingredient 11 words ▾

Active ingredients Calendula Offcianalis 3X PHUS Olive Extract (Oleuropein) 3X HPUS

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Purified water, Hyaluronic Acid 0.05%, Tocopherol Acetate (Vitamin E), Carbomer, Carbomer, Sodium Hyaluron Hydroxide, Sodium Edetate, Hop extract, Organic Olive Oil, Organic Avocado Oil, Olive Fruit Vilin Extract, Taraxacum Mongolicum Extract

🎯 Purpose 9 words ▾

Purpose Moisturizing and Healing Agent Antimicrobial and Healing Agent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85962-0002-01 · Pelotan 85966-0001-01 · GUANGZHOU →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.