Hydro Gyn

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerShenzhen water element e-commerce Co., LTD

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8596400101
10 BAG in 1 BOX (85964-001-01) / 10 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

18E7415PXQ

CALENDULA OFFICINALIS FLOWERING TOP

RxCUI 1309775

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "18E7415PXQ",
    "rxcui": "1309775",
    "inchikey": null,
    "display_name": "CALENDULA OFFICINALIS FLOWERING TOP",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "CUTANEOUS",
  "spl_meta": {
    "3bd3a52d-eaff-1c9f-e063-6394a90abbb6": {
      "match": "brand_token",
      "title": "HYDRO GYN (CALENDULA OFFCIANALIS, OLIVE EXTRACT) GEL [SHENZHEN WATER ELEMENT E-COMMERCE CO., LTD]",
      "spl_version": "1",
      "published_date": "2025-08-11"
    }
  },
  "productid": "85964-001_3bd3a52d-eb00-1c9f-e063-6394a90abbb6",
  "productndc": "85964-001",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CALENDULA OFFICINALIS FLOWERING TOP; OLEUROPEIN",
  "proprietary_name": "Hydro Gyn",
  "active_ingred_unit": "[hp_X]/mL; [hp_X]/mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED HOMEOPATHIC",
  "nonproprietary_name": "Calendula Offcianalis, Olive Extract",
  "start_marketing_date": "20250808",
  "active_numerator_strength": "3; 3"
}

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