{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "4x Medicated Toothache and Gum Cream Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 BENZOCAINE BENZOCAINE SACCHARIN SODIUM SACCHARIN SORBIC ACID TITANIUM DIOXIDE AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN BENZALKONIUM CHLORIDE BENZALKONIUM ZINC CHLORIDE ZINC CATION MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Cloudy"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Benzalkonium chloride 0.13% . . . Oral antiseptic Benzocaine 20% . . . . . . . . . . . . . Oral pain reliever Menthol 0.26% . . . . . . . . . . . . . . .Oral pain reliever Zinc chloride 0.15% . . . . . . . . . . .Oral astringent"
      ],
      "purpose": [
        "Oral antiseptic Oral pain reliever Oral pain reliever Oral astringent Use for the temporary relief of pain due to minor irritation of injury of the mouth and gums first aid to help prevent infection in miro oral irritation"
      ],
      "indications_and_usage": [
        "Use for the temporary relief of pain due to minor irritation of injury of the mouth and gums first aid to help prevent infection in miro oral irritation"
      ],
      "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 more than directed for more than 7 days unless told to do so by a dentist or doctor for teething in children under 2 years of age Stop use and ask a doctor if symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions cut open tip of tube on score mark adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor children under 12 years of age: ask doctor before use. Should be supervised in the use of this product children under 2 years of age: do not use"
      ],
      "inactive_ingredient": [
        "ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, titanium dioxide"
      ],
      "other_safety_information": [
        "Other information do not use if tip is cut prior to opening avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"
      ],
      "package_label_principal_display_panel": [
        "HEB_4xmedicated_toothachecream_ctn_2821611R2"
      ],
      "set_id": "a71c5259-cbcf-7566-e053-2995a90a2cb6",
      "id": "47e513f5-736f-c398-e063-6394a90a025d",
      "effective_time": "20260108",
      "version": "6",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "4x Medicated Toothache and Gum Cream"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "HEB"
        ],
        "product_ndc": [
          "37808-116"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZOCAINE",
          "BENZALKONIUM CHLORIDE",
          "ZINC CHLORIDE",
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "2370903"
        ],
        "spl_id": [
          "47e513f5-736f-c398-e063-6394a90a025d"
        ],
        "spl_set_id": [
          "a71c5259-cbcf-7566-e053-2995a90a2cb6"
        ],
        "package_ndc": [
          "37808-116-69"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041220838189"
        ],
        "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": [
          "U3RSY48JW5",
          "F5UM2KM3W7",
          "86Q357L16B",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}