{
  "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": 7
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Equaline Ear Relief Ear Drops CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR GLYCERIN CHAMOMILE CHAMOMILE MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS SULFUR SULFUR"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Active ingredients are manufactured according to homeopathic principles. Do not use if tamper-evident safety seal is missing or broken."
      ],
      "active_ingredient": [
        "Active ingredients Chamomilla 10X Mercurius solubilis 15X Sulphur 12X Purpose sensitivity to dreafts, soothing fullness, sensitivity to cold itchiness, sensitivity to water"
      ],
      "purpose": [
        "Purpose sensitivity to dreafts, soothing fullness, sensitivity to cold itchiness, sensitivity to water"
      ],
      "indications_and_usage": [
        "Uses Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear."
      ],
      "warnings": [
        "Warnings Do not use in the eyes. Initial exacerbation may occur. Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in the eyes. Initial exacerbation may occur."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness"
      ],
      "stop_use": [
        "Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions FOR USE IN THE EAR ONLY. Remove tamper-evident seal from neck of bottle. Twist cap off bottle. Tilt head sideways. Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal). Keep drops in ear by keeping head tilted or placing cotton in ear. Use up to 4 times daily for no more than 48 hours, or as direted by a doctor. Children under 12 years of age consult a doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredient Vegetable glycerin"
      ],
      "questions": [
        "Questions? 1-855-423-2630"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label2"
      ],
      "set_id": "1178cdcf-860d-42b7-974f-346485311a2f",
      "id": "2f3978df-639b-8d46-e063-6294a90ac8f8",
      "effective_time": "20250228",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Equaline Ear Relief Ear Drops"
        ],
        "generic_name": [
          "CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR"
        ],
        "manufacturer_name": [
          "United Natural Foods, Inc."
        ],
        "product_ndc": [
          "41163-846"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "CHAMOMILE",
          "MERCURIUS SOLUBILIS",
          "SULFUR"
        ],
        "spl_id": [
          "2f3978df-639b-8d46-e063-6294a90ac8f8"
        ],
        "spl_set_id": [
          "1178cdcf-860d-42b7-974f-346485311a2f"
        ],
        "package_ndc": [
          "41163-846-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041163432727"
        ],
        "unii": [
          "FGL3685T2X",
          "324Y4038G2",
          "70FD1KFU70"
        ]
      }
    }
  ]
}