{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Orajel Rescue Relief Pen Oral Pain Reliever ZINC CHLORIDE ZINC CATION MENTHOL MENTHOL AMMONIUM GLYCYRRHIZATE WATER BENZOCAINE BENZOCAINE SORBIC ACID POLYETHYLENE GLYCOL 400 PEG-75 SODIUM SACCHARIN Pale yellow to tan"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%"
      ],
      "purpose": [
        "PURPOSE Oral Pain Reliever / Oral Astringent"
      ],
      "indications_and_usage": [
        "USES • for the temporary relief of • pain due to minor irritation or injury of the mouth and gums • occasional sore mouth and sore throat"
      ],
      "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 • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age STOP USE AND ASK A DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, swelling, rash or fever develops • irritation, pain or redness persists or worsens KEEP OUT OF REACH OF CHILDREN In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "DO NOT USE • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age"
      ],
      "stop_use": [
        "STOP USE AND ASK A DENTIST OR DOCTOR IF • sore throat is severe, persists for more than 2 days • sore mouth symptoms do not improve in 7 days • headache, nausea, vomiting, 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 a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTIONS adults and children 2 years of age and older apply to the affected area up to 4 times daily or as directed by a dentist or doctor children between 2 and 12 years of age ask a doctor before use. Should be supervised in the use of this product. children under 2 years of age do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" width=\"100%\"><tbody><tr><td>adults and children 2 years of age and older</td><td>apply to the affected area up to 4 times daily or as directed by a dentist or doctor</td></tr><tr><td>children between 2 and 12 years of age</td><td>ask a doctor before use. Should be supervised in the use of this product.</td></tr><tr><td>children under 2 years of age</td><td>do not use</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "OTHER INFORMATION • do not use if package has been opened"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS ammonium glycrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water"
      ],
      "questions": [
        "QUESTIONS OR COMMENTS? Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com"
      ],
      "package_label_principal_display_panel": [
        "#1 ORAL PAIN RELIEF BRAND FOR ADULTS Orajel™ TOOTHACHE & GUM IMMEDIATE RELIEF OF: ORAL PAIN BRACE/DENTURE IRRITATION GUM DISCOMFORT CANKER SORES RESCUE RELIEF PEN GENTLE. TARGETED. TOUCH-FREE. PLUS COOLING RELIEF 50+ USES ORAL PAIN RELIEVER / ASTRINGENT NET WT 0.07 OZ (2.0 g) Orajel Pen"
      ],
      "set_id": "2d68eec5-ae8a-9cdf-e063-6294a90a9799",
      "id": "38d791e8-33d3-22e4-e063-6394a90aff90",
      "effective_time": "20250601",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Orajel Rescue Relief Pen"
        ],
        "generic_name": [
          "ORAL PAIN RELIEVER"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-731"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ZINC CHLORIDE",
          "MENTHOL",
          "BENZOCAINE"
        ],
        "rxcui": [
          "2362013"
        ],
        "spl_id": [
          "38d791e8-33d3-22e4-e063-6394a90aff90"
        ],
        "spl_set_id": [
          "2d68eec5-ae8a-9cdf-e063-6294a90a9799"
        ],
        "package_ndc": [
          "10237-731-07",
          "10237-731-27"
        ],
        "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": [
          "86Q357L16B",
          "L7T10EIP3A",
          "U3RSY48JW5"
        ]
      }
    }
  ]
}