{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Collavera Collavera LIDOCAINE LIDOCAINE WATER HYDROXYETHYLCELLULOSE MARINE COLLAGEN, SOLUBLE PHENOXYETHANOL ALOE BARBADENSIS LEAF ETHYLHEXYLGLYCERIN SODIUM HYDROXIDE LACTIC ACID"
      ],
      "description": [
        "DESCRIPTION Collavera™ contains Lidocaine Hydrochloride 20 mg/g (2%) in a topical gel base."
      ],
      "indications_and_usage": [
        "INDICATIONS AND USAGE Collavera™ is indicated for topical analgesia as directed by a healthcare provider."
      ],
      "warnings": [
        "WARNINGS For external use only. Not for ophthalmic use. Avoid contact with eyes. Excessive application may result in systemic absorption. Use only as directed. Keep out of reach of children."
      ],
      "overdosage": [
        "OVERDOSAGE Excessive topical application may increase systemic absorption of lidocaine and may result in central nervous system and cardiovascular effects. In the event of overdose, discontinue use and seek medical attention."
      ],
      "dosage_and_administration": [
        "DOSAGE AND ADMINISTRATION For topical use only. Apply a thin layer to the affected area 3 to 4 times daily or as directed by a healthcare provider. Avoid contact with eyes and mucous membranes."
      ],
      "how_supplied": [
        "HOW SUPPLIED Collavera™ (Lidocaine Hydrochloride 20 mg/g) is supplied as a clear topical gel in a 1 oz (28.33 g) tube. NDC 85477-305-07"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL pdp pdp"
      ],
      "set_id": "88b9fa02-40a7-4fe6-87b8-6787061f5b92",
      "id": "3c0b5871-ff1e-4532-a0de-e378b009e7cd",
      "effective_time": "20260227",
      "version": "1",
      "openfda": {
        "brand_name": [
          "Collavera"
        ],
        "generic_name": [
          "COLLAVERA"
        ],
        "manufacturer_name": [
          "Oncora Pharma, LLC"
        ],
        "product_ndc": [
          "85477-305"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE"
        ],
        "rxcui": [
          "1011852"
        ],
        "spl_id": [
          "3c0b5871-ff1e-4532-a0de-e378b009e7cd"
        ],
        "spl_set_id": [
          "88b9fa02-40a7-4fe6-87b8-6787061f5b92"
        ],
        "package_ndc": [
          "85477-305-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0854770305076"
        ],
        "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"
        ]
      }
    }
  ]
}