{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Lidovara Lidovara LIDOCAINE LIDOCAINE WATER HYDROXYETHYLCELLULOSE PHENOXYETHANOL ETHYLHEXYLGLYCERIN SODIUM HYDROXIDE LACTIC ACID"
      ],
      "description": [
        "DESCRIPTION Lidovara™ is a topical gel containing Lidocaine Hydrochloride 28 mg/g (2.8%)."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Lidovara™ is indicated for topical analgesia as directed by a healthcare provider."
      ],
      "contraindications": [
        "CONTRAINDICATIONS Lidovara™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation."
      ],
      "warnings": [
        "WARNINGS For external use only. Not for ophthalmic use. Avoid contact with eyes. Excessive application may result in increased systemic absorption. Keep out of reach of children."
      ],
      "overdosage": [
        "OVERDOSAGE Excessive topical application may result in increased systemic absorption of lidocaine. In the event of overdose, discontinue use and seek medical attention."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION For topical use only. Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider."
      ],
      "how_supplied": [
        "HOW SUPPLIED Lidovara™ (Lidocaine Hydrochloride 28 mg/g) is supplied as a clear topical gel in a 3.5 oz (100 g) tube. NDC 85477-303-07"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL pdp pdp"
      ],
      "set_id": "93a33939-80e1-4d6d-aa6d-96ca03d95410",
      "id": "66b8ed5e-491a-4ddf-8cc9-eeb817bb688b",
      "effective_time": "20260227",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Lidovara"
        ],
        "generic_name": [
          "LIDOVARA"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-303"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE"
        ],
        "rxcui": [
          "2562183"
        ],
        "spl_id": [
          "66b8ed5e-491a-4ddf-8cc9-eeb817bb688b"
        ],
        "spl_set_id": [
          "93a33939-80e1-4d6d-aa6d-96ca03d95410"
        ],
        "package_ndc": [
          "85477-303-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0854770303072"
        ],
        "nui": [
          "N0000175682",
          "M0000897",
          "N0000175426",
          "N0000175976"
        ],
        "pharm_class_epc": [
          "Amide Local Anesthetic [EPC]",
          "Antiarrhythmic [EPC]"
        ],
        "pharm_class_cs": [
          "Amides [CS]"
        ],
        "pharm_class_pe": [
          "Local Anesthesia [PE]"
        ],
        "unii": [
          "98PI200987"
        ]
      }
    }
  ]
}