{
  "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": "2026-10-30",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Dental Relief benzocaine benzocaine benzocaine polyethylene glycol 400 polyethylene glycol 3350 peppermint oil saccharin sodium sorbic acid"
      ],
      "active_ingredient": [
        "Active Ingredients Benzocaine 20% (w/w)"
      ],
      "purpose": [
        "Purpose Oral antiseptic"
      ],
      "indications_and_usage": [
        "Uses For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances."
      ],
      "warnings": [
        "Warnings For oral use only Allergy alert Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock. When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage. Keep out of reach of children. If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor Consult a dentist or doctor for use on children under 2 years of age Children under 12 years of should be supervised in the use of this product"
      ],
      "spl_unclassified_section": [
        "Other information Do not use if packet is torn, cut or opened Store at room temperature, 15° to 30°C (59° to 86°F) Avoid contact with eyes"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – 0.5 gram Packet Dental Relief Active ingredients: Benzocaine (20%), Compound benzoin tincture USES: Temporarily relieves pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor mouth and gum injuries. Do not use if packet is torn or broken NET WT 0.5g dental-01"
      ],
      "set_id": "0f40f775-797e-43cf-88c9-00eea666494f",
      "id": "8ac8fc4b-8b2d-408d-b9ab-dcacda68471d",
      "effective_time": "20250923",
      "version": "6",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Dental Relief"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "Cintas Corporation"
        ],
        "product_ndc": [
          "42961-810"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "308657"
        ],
        "spl_id": [
          "8ac8fc4b-8b2d-408d-b9ab-dcacda68471d"
        ],
        "spl_set_id": [
          "0f40f775-797e-43cf-88c9-00eea666494f"
        ],
        "package_ndc": [
          "42961-810-02",
          "42961-810-03"
        ],
        "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": [
          "U3RSY48JW5"
        ]
      }
    }
  ]
}