{
  "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": [
        "Equate Orasol 20% Benzocaine BENZYL ALCOHOL CARBOMER 940 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL 3350 PROPYLENE GLYCOL SACCHARIN SODIUM BENZOCAINE BENZOCAINE"
      ],
      "warnings_and_cautions": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Benzocaine 20%"
      ],
      "purpose": [
        "Purpose Oral Pain Reliever"
      ],
      "indications_and_usage": [
        "Uses temporary relief of occasional minor irritation, pain and sore mouth"
      ],
      "warnings": [
        "Warnings Methemoglobinema Warning: Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor 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 told to do so by a dentist or doctor"
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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 do not use tube if it is cut prior to opening cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel apply to affected area up to four times daily or as directed by a dentist or physician Adults and children 2 years of age and older: Apply to affected area Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin"
      ],
      "other_safety_information": [
        "Other information store at a controlled room temperature 68°- 77°F (20°-25°C)"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC 79903-966-09 Oral Pain Relief MAXIMUM STRENGTH GEL Benzocaine 20% NET WT. 0.33 OZ (9.35g) Walmart_Orasol_0.33oz Carton Walmart_Orasol_0.33oz Tube"
      ],
      "set_id": "08404780-8252-4484-b1c3-8970803f74f8",
      "id": "48c33201-4ce3-aaf0-e063-6394a90a8b04",
      "effective_time": "20260119",
      "version": "3",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Equate Orasol"
        ],
        "generic_name": [
          "20% BENZOCAINE"
        ],
        "manufacturer_name": [
          "WAL-MART STORES INC."
        ],
        "product_ndc": [
          "79903-966"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZOCAINE"
        ],
        "rxcui": [
          "238910"
        ],
        "spl_id": [
          "48c33201-4ce3-aaf0-e063-6394a90a8b04"
        ],
        "spl_set_id": [
          "08404780-8252-4484-b1c3-8970803f74f8"
        ],
        "package_ndc": [
          "79903-966-09"
        ],
        "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"
        ]
      }
    }
  ]
}