{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "54973-3324",
      "generic_name": "Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude",
      "labeler_name": "Hyland' Inc.",
      "brand_name": "Baby Nighttime Oral Pain Relief",
      "active_ingredients": [
        {
          "name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE",
          "strength": "12 [hp_X]/g"
        },
        {
          "name": "TRIBASIC CALCIUM PHOSPHATE",
          "strength": "12 [hp_X]/g"
        },
        {
          "name": "MATRICARIA CHAMOMILLA",
          "strength": "12 [hp_X]/g"
        },
        {
          "name": "SILICON DIOXIDE",
          "strength": "12 [hp_X]/g"
        },
        {
          "name": "ARNICA MONTANA",
          "strength": "30 [hp_X]/g"
        },
        {
          "name": "FERROSOFERRIC PHOSPHATE",
          "strength": "12 [hp_X]/g"
        },
        {
          "name": "ARABICA COFFEE BEAN",
          "strength": "6 [hp_X]/g"
        },
        {
          "name": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
          "strength": "12 [hp_X]/g"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "54973-3324-1",
          "description": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1)  / 1 g in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "20170817",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Hyland' Inc."
        ],
        "spl_set_id": [
          "58ef86b7-5b38-1591-e053-2991aa0aa53e"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "M0516536"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
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          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
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          "Dietary Proteins [CS]",
          "Plant Proteins [CS]",
          "Seed Storage Proteins [CS]"
        ],
        "unii": [
          "2E32821G6I",
          "91D9GV0Z28",
          "G0R4UBI2ZZ",
          "ETJ7Z6XBU4",
          "O80TY208ZW",
          "91GQH8I5F7",
          "3SW678MX72",
          "HF539G9L3Q"
        ]
      },
      "marketing_category": "UNAPPROVED HOMEOPATHIC",
      "dosage_form": "TABLET",
      "spl_id": "308ccf50-c319-2cd0-e063-6394a90aa99e",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20170817",
      "product_id": "54973-3324_308ccf50-c319-2cd0-e063-6394a90aa99e",
      "brand_name_base": "Baby Nighttime Oral Pain Relief",
      "pharm_class": [
        "Allergens [CS]",
        "Calculi Dissolution Agent [EPC]",
        "Cell-mediated Immunity [PE]",
        "Dietary Proteins [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]",
        "Seed Storage Proteins [CS]",
        "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
      ]
    }
  ]
}