{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Esokalli Testosterone Booster Oral Dissolving Film Esokalli Testosterone Booster Oral Dissolving Film TADALAFIL TADALAFIL VARDENAFIL VARDENAFIL HYPROMELLOSES SUCRALOSE SUCROSE"
      ],
      "components": [
        "Active ingredients (in each film) Tadalafil 20 mg – Erectile dysfunction treatment Vardenafil 20 mg – Erectile dysfunction treatment"
      ],
      "purpose": [
        "Purpose Phosphodiesterase type 5 (PDE5) inhibitors"
      ],
      "indications_and_usage": [
        "Uses For the treatment of erectile dysfunction (ED)"
      ],
      "warnings": [
        "Warnings For prescription use only (Rx only). Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension. Do not use if allergic to tadalafil, vardenafil, or any component of this product."
      ],
      "dosage_and_administration": [
        "Dosage and administration For external use only."
      ],
      "do_not_use": [
        "Do not use heart problems, history of heart attack, irregular heartbeat, or chest pain high or low blood pressure liver or kidney disease vision or hearing problems history of priapism (painful or prolonged erection lasting >4 hours)"
      ],
      "when_using": [
        "When using this product you may experience: headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances"
      ],
      "stop_use": [
        "Stop use and ask a doctor if: you experience chest pain, fainting, sudden vision or hearing loss an erection lasts longer than 4 hours (priapism). This is a medical emergency."
      ],
      "keep_out_of_reach_of_children": [
        "Contraindications Pregnant or breastfeeding women Children under 18 years"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Film-forming polymers, stabilizers, sweeteners, flavoring agents."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL 1 2 3 4"
      ],
      "set_id": "3d1ee1c9-96ab-2a0f-e063-6394a90a3eb9",
      "id": "3d1ee1c9-96ac-2a0f-e063-6394a90a3eb9",
      "effective_time": "20250824",
      "version": "1",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Esokalli Testosterone Booster Oral Dissolving Film"
        ],
        "generic_name": [
          "ESOKALLI TESTOSTERONE BOOSTER ORAL DISSOLVING FILM"
        ],
        "manufacturer_name": [
          "Guangzhou Yixin Cross-border E-commerce Co., Ltd."
        ],
        "product_ndc": [
          "84778-079"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TADALAFIL",
          "VARDENAFIL"
        ],
        "spl_id": [
          "3d1ee1c9-96ac-2a0f-e063-6394a90a3eb9"
        ],
        "spl_set_id": [
          "3d1ee1c9-96ab-2a0f-e063-6394a90a3eb9"
        ],
        "package_ndc": [
          "84778-079-01",
          "84778-079-02",
          "84778-079-03",
          "84778-079-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175599",
          "N0000020026"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 5 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 5 Inhibitors [MoA]"
        ],
        "unii": [
          "742SXX0ICT",
          "UCE6F4125H"
        ]
      }
    }
  ]
}