{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 69
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Ear Ringing Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata ALCOHOL ACONITUM NAPELLUS ACONITUM NAPELLUS BARIUM CARBONATE BARIUM CATION BARIUM CHLORIDE DIHYDRATE BARIUM CATION CAPSICUM CAPSICUM CAUSTICUM CAUSTICUM DYSPHANIA AMBROSIOIDES DYSPHANIA AMBROSIOIDES QUININE SULFATE QUININE CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK NITROGLYCERIN NITROGLYCERIN GRAPHITE GRAPHITE GOLDENSEAL GOLDENSEAL POTASSIUM DICHROMATE DICHROMATE ION POTASSIUM CHLORIDE POTASSIUM CATION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE PHOSPHORUS PHOSPHORUS PULSATILLA VULGARIS PULSATILLA VULGARIS SALICYLIC ACID SALICYLIC ACID TOBACCO LEAF TOBACCO LEAF ALLYLTHIOUREA ALLYLTHIOUREA VIOLA ODORATA VIOLA ODORATA"
      ],
      "indications_and_usage": [
        "INDICATIONS & USAGE SECTION Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise."
      ],
      "dosage_and_administration": [
        "DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose."
      ],
      "active_ingredient": [
        "OTC - ACTIVE INGREDIENT SECTION Equal parats of Hydrastis 6x, Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x."
      ],
      "purpose": [
        "OTC - PURPOSE SECTION Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%"
      ],
      "questions": [
        "QUESTIONS SECTION newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013"
      ],
      "warnings": [
        "WARNINGS SECTION WARNINGS : Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feedin g, ask a doctor before use."
      ],
      "pregnancy_or_breast_feeding": [
        "OTC - PREGNANCY OR BREAST FEEDING SECTION WARNINGS : If pregnant or breast-feedin g, ask a doctor before use."
      ],
      "keep_out_of_reach_of_children": [
        "OTC - KEEP OUT OF REACH OF CHILDREN SECTION WARNINGS: Keep out of reach of children."
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL package label"
      ],
      "set_id": "1043debe-8787-a2f5-e063-6294a90a2a66",
      "id": "10437086-0291-3a3b-e063-6294a90af4e4",
      "effective_time": "20240131",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Ear Ringing"
        ],
        "generic_name": [
          "ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA"
        ],
        "manufacturer_name": [
          "Newton Laboratories, Inc."
        ],
        "product_ndc": [
          "55714-2588"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACONITUM NAPELLUS",
          "ALLYLTHIOUREA",
          "BARIUM CARBONATE",
          "BARIUM CHLORIDE DIHYDRATE",
          "CAPSICUM",
          "CAUSTICUM",
          "CINCHONA OFFICINALIS BARK",
          "DYSPHANIA AMBROSIOIDES",
          "GOLDENSEAL",
          "GRAPHITE",
          "LYCOPODIUM CLAVATUM SPORE",
          "NITROGLYCERIN",
          "PHOSPHORUS",
          "POTASSIUM CHLORIDE",
          "POTASSIUM DICHROMATE",
          "PULSATILLA VULGARIS",
          "QUININE SULFATE",
          "SALICYLIC ACID",
          "TOBACCO LEAF",
          "VIOLA ODORATA"
        ],
        "spl_id": [
          "10437086-0291-3a3b-e063-6294a90af4e4"
        ],
        "spl_set_id": [
          "1043debe-8787-a2f5-e063-6294a90a2a66"
        ],
        "package_ndc": [
          "55714-2588-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185375",
          "N0000185371",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "M0022575",
          "N0000175415",
          "M0014874",
          "N0000009909",
          "N0000185001"
        ],
        "pharm_class_epc": [
          "Non-Standardized Plant Allergenic Extract [EPC]",
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Nitrate Vasodilator [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Vasodilation [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]",
          "Vegetable Proteins [CS]",
          "Nitrates [CS]"
        ],
        "unii": [
          "U0NQ8555JD",
          "706IDJ14B7",
          "6P669D8HQ8",
          "EL5GJ3U77E",
          "00UK7646FG",
          "DD5FO1WKFU",
          "S003A158SB",
          "4H5RSU087I",
          "ZW3Z11D0JV",
          "4QQN74LH4O",
          "C88X29Y479",
          "G59M7S0WS3",
          "27YLU75U4W",
          "660YQ98I10",
          "T4423S18FM",
          "I76KB35JEV",
          "KF7Z0E0Q2B",
          "O414PZ4LPZ",
          "6YR2608RSU",
          "AET12U8B74"
        ]
      }
    }
  ]
}