{
  "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": [
        "Quality Choice Oral Pain Relief Benzocaine 20%, Benzalkonium Chloride 1% WATER POLYETHYLENE GLYCOL 400 SODIUM POLYACRYLATE (8000 MW) SACCHARIN SODIUM SORBIC ACID SORBITOL GLYCERIN PROPYLENE GLYCOL BENZOCAINE BENZOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM"
      ],
      "active_ingredient": [
        "Active ingredients 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 infection in minor oral irritation"
      ],
      "warnings": [
        "Warnings Methemoglobinemia warning : use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ■ pale, gray or blue-colored skin (cyanosis) ■ headache ■ rapid heart rate ■ shortness of breath ■ dizziness or lightheadedness ■ fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, 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 for teething in children under 2 years of age"
      ],
      "ask_doctor": [
        "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 (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and over - Apply a small amount of 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 of age - Should be supervised in the use of this product Children under 2 years of age -do not use"
      ],
      "other_safety_information": [
        "Other information this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician 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 store at 20-25C (68-77F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, PEG 400, propylene glycol, sorbitol, sodium saccharine, sorbic acid, sodium polyacrylate,strawberry flavor, water"
      ],
      "questions": [
        "Questions or comments? TOLL FREE 800-935-2362"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "162702b4-4bf7-8868-e063-6294a90a5921",
      "id": "16271ed7-9c13-93e0-e063-6294a90a1adc",
      "effective_time": "20240415",
      "version": "1",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Quality Choice Oral Pain Relief"
        ],
        "generic_name": [
          "BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%"
        ],
        "manufacturer_name": [
          "Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)"
        ],
        "product_ndc": [
          "83324-035"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE",
          "BENZOCAINE"
        ],
        "spl_id": [
          "16271ed7-9c13-93e0-e063-6294a90a1adc"
        ],
        "spl_set_id": [
          "162702b4-4bf7-8868-e063-6294a90a5921"
        ],
        "package_ndc": [
          "83324-035-12"
        ],
        "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"
        ]
      }
    }
  ]
}