{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "54973-3257",
      "generic_name": "avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower",
      "labeler_name": "Hyland's Inc.",
      "brand_name": "CALMS FORTE",
      "active_ingredients": [
        {
          "name": "AVENA SATIVA FLOWERING TOP",
          "strength": "4 [hp_X]/1"
        },
        {
          "name": "TRIBASIC CALCIUM PHOSPHATE",
          "strength": "3 [hp_X]/1"
        },
        {
          "name": "MATRICARIA RECUTITA",
          "strength": "4 [hp_X]/1"
        },
        {
          "name": "FERROSOFERRIC PHOSPHATE",
          "strength": "3 [hp_X]/1"
        },
        {
          "name": "HOPS",
          "strength": "4 [hp_X]/1"
        },
        {
          "name": "POTASSIUM PHOSPHATE, DIBASIC",
          "strength": "3 [hp_X]/1"
        },
        {
          "name": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
          "strength": "3 [hp_X]/1"
        },
        {
          "name": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
          "strength": "3 [hp_X]/1"
        },
        {
          "name": "PASSIFLORA INCARNATA FLOWER",
          "strength": "4 [hp_X]/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "54973-3257-1",
          "description": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3257-1)  / 50 TABLET in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "20160429",
          "sample": false
        },
        {
          "package_ndc": "54973-3257-2",
          "description": "100 TABLET in 1 BOTTLE, PLASTIC (54973-3257-2)",
          "marketing_start_date": "20160429",
          "sample": false
        },
        {
          "package_ndc": "54973-3257-3",
          "description": "4 TABLET in 1 BOTTLE, PLASTIC (54973-3257-3)",
          "marketing_start_date": "20160429",
          "sample": false
        },
        {
          "package_ndc": "54973-3257-7",
          "description": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3257-7)  / 100 TABLET in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "20160429",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Hyland's Inc."
        ],
        "spl_set_id": [
          "63ce9942-a299-4d9b-b63b-35b297472dc9"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "M0008672"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]",
          "Food Additives [CS]"
        ],
        "unii": [
          "MA9CQJ3F7F",
          "91D9GV0Z28",
          "G0R4UBI2ZZ",
          "91GQH8I5F7",
          "01G73H6H83",
          "CI71S98N1Z",
          "HF539G9L3Q",
          "70WT22SF4B",
          "K8F3G29S6Z"
        ]
      },
      "marketing_category": "UNAPPROVED HOMEOPATHIC",
      "dosage_form": "TABLET",
      "spl_id": "58f195ef-ccf8-4142-e063-6394a90aa962",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20160429",
      "product_id": "54973-3257_58f195ef-ccf8-4142-e063-6394a90aa962",
      "brand_name_base": "CALMS FORTE",
      "pharm_class": [
        "Allergens [CS]",
        "Calculi Dissolution Agent [EPC]",
        "Cell-mediated Immunity [PE]",
        "Dietary Proteins [CS]",
        "Food Additives [CS]",
        "Increased Histamine Release [PE]",
        "Increased Large Intestinal Motility [PE]",
        "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
        "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]",
        "Magnesium Ion Exchange Activity [MoA]",
        "Non-Standardized Food Allergenic Extract [EPC]",
        "Non-Standardized Plant Allergenic Extract [EPC]",
        "Osmotic Activity [MoA]",
        "Osmotic Laxative [EPC]",
        "Plant Proteins [CS]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}