{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Lidexa Lidexa LIDOCAINE LIDOCAINE"
      ],
      "description": [
        "DESCRIPTION Lidexa™ (Lidocaine Hydrochloride) Cream 38.8"
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Lidexa™ is indicated for topical analgesia as directed by a healthcare provider."
      ],
      "contraindications": [
        "CONTRAINDICATIONS Lidexa™ 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."
      ],
      "precautions": [
        "PRECAUTIONS Use only as directed. If irritation occurs, discontinue use and consult a healthcare provider. General Drug Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Nursing Mothers Pediatric Use"
      ],
      "general_precautions": [
        "General"
      ],
      "drug_interactions": [
        "Drug Interactions"
      ],
      "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [
        "Carcinogenesis, Mutagenesis, Impairment of Fertility"
      ],
      "pregnancy": [
        "Pregnancy"
      ],
      "nursing_mothers": [
        "Nursing Mothers"
      ],
      "pediatric_use": [
        "Pediatric Use"
      ],
      "adverse_reactions": [
        "ADVERSE REACTIONS Localized skin reactions such as redness, irritation, or rash may occur."
      ],
      "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 Lidexa™ (Lidocaine Hydrochloride 38.8 mg/g) is supplied as a white topical cream in a 3 oz (85 g) tube. NDC 85477-330-07"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL pdp pdp"
      ],
      "set_id": "46d6b3b8-3a9a-44c2-b807-a32f24945f4a",
      "id": "cb6c85bc-f245-431d-8ded-4a4d8c83dbb2",
      "effective_time": "20260227",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Lidexa"
        ],
        "generic_name": [
          "LIDEXA"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-330"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE"
        ],
        "rxcui": [
          "1723991"
        ],
        "spl_id": [
          "cb6c85bc-f245-431d-8ded-4a4d8c83dbb2"
        ],
        "spl_set_id": [
          "46d6b3b8-3a9a-44c2-b807-a32f24945f4a"
        ],
        "package_ndc": [
          "85477-330-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0854770330078"
        ],
        "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"
        ]
      }
    }
  ]
}