{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Gynobalance Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone PRASTERONE PRASTERONE ESTRADIOL ESTRADIOL PREGNENOLONE PREGNENOLONE PROGESTERONE PROGESTERONE TESTOSTERONE TESTOSTERONE ANHYDROUS CITRIC ACID GLYCERIN SODIUM BENZOATE WATER ALCOHOL"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: DHEA (Dehydroepiandrosterone) 6X, Estradiol 8X, Pregnenolone 8X, Progesterone 8X, Testosterone 8X."
      ],
      "purpose": [
        "INDICATIONS: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity."
      ],
      "warnings": [
        "WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTIONS: Three sprays per day. Hold in mouth for two minutes."
      ],
      "indications_and_usage": [
        "INDICATIONS: For temporary relief of symptoms due to menopausal hot flashes, loss of libido; may enhance calcium metabolism, feelings of well-being and mental clarity."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Citric Acid, Demineralized Water, Ethanol 0.07%, Glycerin, Sodium Benzoate."
      ],
      "questions": [
        "QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL DISPLAY: BIO Active Nutritional GYNOBALANCE HOMEOPATHIC 1 FL OZ (30 ml) Gynobalance"
      ],
      "set_id": "61fa6e6e-42f5-4992-87b5-0770218abc8c",
      "id": "24deb803-ab80-49ec-81e5-4ef5ce24fcf5",
      "effective_time": "20230810",
      "version": "5",
      "openfda": {
        "brand_name": [
          "Gynobalance"
        ],
        "generic_name": [
          "DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE"
        ],
        "manufacturer_name": [
          "BioActive Nutritional, Inc."
        ],
        "product_ndc": [
          "43857-0033"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PRASTERONE",
          "ESTRADIOL",
          "PREGNENOLONE",
          "PROGESTERONE",
          "TESTOSTERONE"
        ],
        "spl_id": [
          "24deb803-ab80-49ec-81e5-4ef5ce24fcf5"
        ],
        "spl_set_id": [
          "61fa6e6e-42f5-4992-87b5-0770218abc8c"
        ],
        "package_ndc": [
          "43857-0033-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100",
          "M0017672",
          "N0000175601",
          "N0000175824",
          "N0000000146",
          "M0001109"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]",
          "Progesterone [CS]",
          "Androstanes [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]",
          "Progesterone [EPC]",
          "Androgen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]",
          "Androgen Receptor Agonists [MoA]"
        ],
        "unii": [
          "459AG36T1B",
          "4TI98Z838E",
          "73R90F7MQ8",
          "4G7DS2Q64Y",
          "3XMK78S47O"
        ]
      }
    }
  ]
}