{
  "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": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Orajel Cold Sore Moisturelock Benzocaine MEDIUM-CHAIN TRIGLYCERIDES PRUNELLA VULGARIS LEAF TITANIUM DIOXIDE FD&C YELLOW NO. 5 PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE CORN OIL CHOLECALCIFEROL FERRIC OXIDE RED FD&C BLUE NO. 1 TOCOPHEROL BENZOCAINE BENZOCAINE ALLANTOIN ALLANTOIN CAMPHOR (NATURAL) CAMPHOR (NATURAL) DIMETHICONE DIMETHICONE MENTHOL MENTHOL PETROLATUM PETROLATUM"
      ],
      "active_ingredient": [
        "Allantoin 0.5% Benzocaine 20% Camphor 3% Dimethicone 2% Menthol 1% White petrolatum 64%"
      ],
      "purpose": [
        "Allantoin - Skin protectant Benzocaine - Topical anesthetic Camphor - Topical analgesic Dimethicone - Skin protectant Menthol - Topical analgesic White petrolatum - Skin protectant"
      ],
      "indications_and_usage": [
        "Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters"
      ],
      "warnings": [
        "For external use only. Allergy alert: do not use 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"
      ],
      "when_using": [
        "When using this product • do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a physician if • conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few 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 or allergic reaction, get medical help or contact Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions • squeeze tube to dispense • blend well until green tint disappears • rub in gently Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Ask a physician Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30ºC (59-86º) under dry conditions • this is a personal care item and should be used by one individual only"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients caprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake"
      ],
      "questions": [
        "Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com"
      ],
      "package_label_principal_display_panel": [
        "Orajel Instan Pain Relief FOR COLD SORES MOISTURELOCK FORMULA Helps Speed Healing Treats 6 Symptoms: 1 Pain 2 Itching 3 Redness 4 Scabbing 5 Cracking 6 Dryness PLUS Helps Minimize Appearance of Cold Sores Topical Anesthetic/Topical Analgesic/Skin Protectant NET WT 0.105 OZ (3g) FT_OJBC-99882-04 BK_OJBC-99882-04"
      ],
      "set_id": "3761c7b3-053b-0f50-e054-00144ff88e88",
      "id": "27d37e6f-4fd8-ce0e-e063-6394a90ad259",
      "effective_time": "20241126",
      "version": "8",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Orajel Cold Sore Moisturelock"
        ],
        "generic_name": [
          "BENZOCAINE"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-761"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOCAINE",
          "ALLANTOIN",
          "CAMPHOR (NATURAL)",
          "DIMETHICONE",
          "MENTHOL",
          "PETROLATUM"
        ],
        "rxcui": [
          "2257305"
        ],
        "spl_id": [
          "27d37e6f-4fd8-ce0e-e063-6394a90ad259"
        ],
        "spl_set_id": [
          "3761c7b3-053b-0f50-e054-00144ff88e88"
        ],
        "package_ndc": [
          "10237-761-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310310998820"
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "N0000010282"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Skin Barrier Activity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "U3RSY48JW5",
          "344S277G0Z",
          "N20HL7Q941",
          "92RU3N3Y1O",
          "L7T10EIP3A",
          "4T6H12BN9U"
        ]
      }
    }
  ]
}