{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "GDS-Calm Digestive Balance ALCOHOL WATER HORSE CHESTNUT HORSE CHESTNUT CHRYSOPOGON ZIZANIOIDES ROOT CHRYSOPOGON ZIZANIOIDES ROOT CHAMAEMELUM NOBILE CHAMAEMELUM NOBILE CANDIDA ALBICANS CANDIDA ALBICANS HELIANTHEMUM CANADENSE HELIANTHEMUM CANADENSE SYZYGIUM JAMBOS SEED SYZYGIUM JAMBOS SEED LILIUM LANCIFOLIUM WHOLE FLOWERING LILIUM LANCIFOLIUM WHOLE FLOWERING VIROLA SEBIFERA RESIN VIROLA SEBIFERA RESIN ASPIDOSPERMA QUEBRACHO-BLANCO BARK ASPIDOSPERMA QUEBRACHO-BLANCO BARK ROBINIA PSEUDOACACIA BARK ROBINIA PSEUDOACACIA BARK"
      ],
      "active_ingredient": [
        "GDS-Calm Aesculus Hippocastanum 7X Eugenia Jambosa 7X Anatherum Muricatum 7X Lilium Tigrinum 15X Anthemis Nobilis 14X Myristica Sebifera 7X Candida Albicans 14X Quebracho 6X Cistus Canadensis 8X Robinia Pseudoacacia 7X"
      ],
      "inactive_ingredient": [
        "GDS-Calm Alcohol, Purified Water"
      ],
      "warnings": [
        "GDS-Calm Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missingl."
      ],
      "keep_out_of_reach_of_children": [
        "GDS-Calm Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "indications_and_usage": [
        "GDS-Calm For the temporary relief of stomach upset, flatulence and heartburn."
      ],
      "dosage_and_administration": [
        "GDS-Calm Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage."
      ],
      "purpose": [
        "GDS-Calm Digestive tract calming."
      ],
      "package_label_principal_display_panel": [
        "GDS-Calm Label"
      ],
      "set_id": "138bfd5e-6586-4fec-bd77-469bad10d1da",
      "id": "462f5aa4-db6b-26dd-e063-6294a90a4030",
      "effective_time": "20251217",
      "version": "8",
      "openfda": {
        "brand_name": [
          "GDS-Calm"
        ],
        "generic_name": [
          "DIGESTIVE BALANCE"
        ],
        "manufacturer_name": [
          "Vitality Works, Inc."
        ],
        "product_ndc": [
          "64616-092"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ASPIDOSPERMA QUEBRACHO-BLANCO BARK",
          "CANDIDA ALBICANS",
          "CHAMAEMELUM NOBILE",
          "CHRYSOPOGON ZIZANIOIDES ROOT",
          "HELIANTHEMUM CANADENSE",
          "HORSE CHESTNUT",
          "LILIUM LANCIFOLIUM WHOLE FLOWERING",
          "ROBINIA PSEUDOACACIA BARK",
          "SYZYGIUM JAMBOS SEED",
          "VIROLA SEBIFERA RESIN"
        ],
        "spl_id": [
          "462f5aa4-db6b-26dd-e063-6294a90a4030"
        ],
        "spl_set_id": [
          "138bfd5e-6586-4fec-bd77-469bad10d1da"
        ],
        "package_ndc": [
          "64616-092-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185372",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0008890",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Non-Standardized Fungal Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Fungal Proteins [CS]",
          "Allergens [CS]"
        ],
        "unii": [
          "52B1340190",
          "4D7G21HDBC",
          "7NF3GE7IWR",
          "37TB8LUP9Z",
          "46G3W789Q3",
          "3C18L6RJAZ",
          "X67Z2963PI",
          "7TPC058OWY",
          "97P0H45869",
          "GHJ5XX5SGS"
        ]
      }
    }
  ]
}