{
  "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,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Oral Gel Oral Pain Relief Benzocaine Benzalkonium Chloride AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL, UNSPECIFIED SACCHARIN SODIUM SORBIC ACID BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM"
      ],
      "active_ingredient": [
        "Active Ingredient Benzocaine 20% Benzalkonium Chloride 0.1%"
      ],
      "purpose": [
        "Purpose Oral pain reliever Antiseptic"
      ],
      "indications_and_usage": [
        "Use ■ for the temporary relief of pain due to toothaches ■ to help protect against infectionin minor oral irritation"
      ],
      "warnings": [
        "Warnings ■ Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine or other \"caine\" anesthetics"
      ],
      "do_not_use": [
        "Do not use ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider"
      ],
      "stop_use": [
        "Stop use and ask a physician if ■ swelling, rash or fever develops ■ irritation, pain or redness persists or worsens ■ symptoms do not improve in 7 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away"
      ],
      "dosage_and_administration": [
        "Directions ■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider ■ children under 12 years: should be supervised in the use of this product ■ children under 2 years of age: ask a physician or health care provider"
      ],
      "spl_unclassified_section": [
        "Other information ■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted ■ do not use continuously ■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid"
      ],
      "package_label_principal_display_panel": [
        "Package Label image description"
      ],
      "set_id": "05ede7e4-5a0a-c942-e063-6294a90a8a24",
      "id": "299dca27-d254-e6ea-e063-6394a90a4f74",
      "effective_time": "20241219",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Oral Gel Oral Pain Relief"
        ],
        "generic_name": [
          "BENZOCAINE BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Savvy Care and Cosmetics"
        ],
        "product_ndc": [
          "83650-101"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE",
          "BENZOCAINE"
        ],
        "rxcui": [
          "1595155"
        ],
        "spl_id": [
          "299dca27-d254-e6ea-e063-6394a90a4f74"
        ],
        "spl_set_id": [
          "05ede7e4-5a0a-c942-e063-6294a90a8a24"
        ],
        "package_ndc": [
          "83650-101-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "F5UM2KM3W7",
          "U3RSY48JW5"
        ]
      }
    }
  ]
}