{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Crataegus Combination 9220 Crataegus Combination HAWTHORN LEAF WITH FLOWER HAWTHORN LEAF WITH FLOWER SPIGELIA ANTHELMIA WHOLE SPIGELIA ANTHELMIA WHOLE POTASSIUM CARBONATE CARBONATE ION ARNICA MONTANA WHOLE ARNICA MONTANA WHOLE SELENICEREUS GRANDIFLORUS STEM SELENICEREUS GRANDIFLORUS STEM GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT CASTOR FIBER SCENT GLAND SECRETION CASTOR FIBER SCENT GLAND SECRETION NITROGLYCERIN NITROGLYCERIN RANUNCULUS BULBOSUS WHOLE RANUNCULUS BULBOSUS WHOLE SULFUR SULFUR ALCOHOL WATER"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Crataegus 1X Spigelia anthelmia 2X Kali carbonicum 3X Arnica montana 4X Cactus grandiflorus 4X Gelsemium sempervirens 4X Castoreum 6X Glonoinum 6X Ranunculus bulbosus 6X Sulphur 12X"
      ],
      "questions": [
        "QUESTIONS Professional Formulas PO Box 2034 Lake Oswego, OR 97035"
      ],
      "indications_and_usage": [
        "INDICATIONS For the temporary relief of occasional insomnia, restlessness, or anxiousness.*"
      ],
      "purpose": [
        "*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
      ],
      "warnings": [
        "WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, ask a healthcare professional before use."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age."
      ],
      "other_safety_information": [
        "OTHER INFORMATION Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS 40% ethanol, purified water."
      ],
      "package_label_principal_display_panel": [
        "LABEL Est 1985 Professional Formulas Complementary Health Crataegus Combination Homeopathic Remedy 1 FL. OZ. (29.5 mL) Label image"
      ],
      "set_id": "ad44d561-9004-43f1-8271-ef52b715fa66",
      "id": "a4cf1cd9-4742-4698-95a6-d7601dda94ea",
      "effective_time": "20260108",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Crataegus Combination 9220"
        ],
        "generic_name": [
          "CRATAEGUS COMBINATION"
        ],
        "manufacturer_name": [
          "Professional Complementary Health Formulas"
        ],
        "product_ndc": [
          "63083-9220"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HAWTHORN LEAF WITH FLOWER",
          "SPIGELIA ANTHELMIA WHOLE",
          "POTASSIUM CARBONATE",
          "ARNICA MONTANA WHOLE",
          "SELENICEREUS GRANDIFLORUS STEM",
          "GELSEMIUM SEMPERVIRENS ROOT",
          "CASTOR FIBER SCENT GLAND SECRETION",
          "NITROGLYCERIN",
          "RANUNCULUS BULBOSUS WHOLE",
          "SULFUR"
        ],
        "spl_id": [
          "a4cf1cd9-4742-4698-95a6-d7601dda94ea"
        ],
        "spl_set_id": [
          "ad44d561-9004-43f1-8271-ef52b715fa66"
        ],
        "package_ndc": [
          "63083-9220-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175415",
          "M0014874",
          "N0000009909"
        ],
        "pharm_class_epc": [
          "Nitrate Vasodilator [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrates [CS]"
        ],
        "pharm_class_pe": [
          "Vasodilation [PE]"
        ],
        "unii": [
          "6OM09RPY36",
          "WYT05213GE",
          "BQN1B9B9HA",
          "O80TY208ZW",
          "7114SV0MYK",
          "639KR60Q1Q",
          "9X8XFD5ZQX",
          "G59M7S0WS3",
          "AEQ8NXJ0MB",
          "70FD1KFU70"
        ]
      }
    }
  ]
}