{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Capsaicin 0.03% Patch Capsaicin 0.03% CAPSAICIN CAPSAICIN ACRYLIC ACID POLYSORBATE 80 GLYCERIN SORBITOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MAGNESIUM ALUMINUM SILICATE PHENOXYETHANOL EDETATE DISODIUM LEMON OIL, COLD PRESSED WATER PEPPERMINT OIL"
      ],
      "spl_unclassified_section": [
        "​ Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Capsaicin 0.03%"
      ],
      "purpose": [
        "Purpose Topical analgesic"
      ],
      "indications_and_usage": [
        "Uses For temporary relief of pain"
      ],
      "warnings": [
        "Warnings (​For external use only) Do not use more than 1 patch at a time on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering condition worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days 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 more than 1 patch at a time on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product"
      ],
      "when_using": [
        "When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly"
      ],
      "stop_use": [
        "Stop use and ask a doctor if localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering condition worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days"
      ],
      "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 Adult and children 12 years of age and over : clean and dry affected area apply 1 patch at a time to affected area,not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age : consult a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Poly(acrylic acid) solution,Polysorbate 80,Glycerin,SORBITOL,Carboxymethyl Cellulose Sodium, aluminium magnesium silicate,PHENOXYETHANOL, EDTA Disodium salt,Lemon oil,Water, Peppermint oil."
      ],
      "storage_and_handling": [
        "Other information Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC: 82461- 418-10 Medcore LLC Capsaicin 0.03% Pain Relieving Hydrogel Technology Contains: 10 Patches Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920 Store in a dry, cool place. For Comments or Questions, call 908-280-2269 Capsaicin"
      ],
      "set_id": "1046c073-c270-4be3-89f2-e8c91f1af97b",
      "id": "1f68a068-2ae3-476e-92e3-4b03c0f0762f",
      "effective_time": "20251104",
      "version": "1",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Capsaicin 0.03% Patch"
        ],
        "generic_name": [
          "CAPSAICIN 0.03%"
        ],
        "manufacturer_name": [
          "Medcore LLC"
        ],
        "product_ndc": [
          "82461-418"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CAPSAICIN"
        ],
        "rxcui": [
          "2727393"
        ],
        "spl_id": [
          "1f68a068-2ae3-476e-92e3-4b03c0f0762f"
        ],
        "spl_set_id": [
          "1046c073-c270-4be3-89f2-e8c91f1af97b"
        ],
        "package_ndc": [
          "82461-418-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "S07O44R1ZM"
        ]
      }
    }
  ]
}