{
  "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": [
        "Orajel Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide and Menthol FD&C BLUE NO. 1 EDETATE DISODIUM METHYL SALICYLATE PHOSPHORIC ACID POLOXAMER 338 POLYSORBATE 20 SACCHARIN SODIUM SORBITOL WATER ALCOHOL HYDROGEN PEROXIDE HYDROGEN PEROXIDE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM"
      ],
      "active_ingredient": [
        "Hydrogen peroxide 1.5% Menthol 0.1%"
      ],
      "purpose": [
        "Oral debriding agent/Oral antiseptic Oral pain reliever"
      ],
      "indications_and_usage": [
        "first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums Aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth"
      ],
      "warnings": [
        "When using this product do not swallow do not exceed recommended dosage Do not use this product for more than 7 days unless directed by a dentist or healthcare provider Stop use and see your physician promptly if swallowing, rash or fever develops; irritation, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "do_not_use": [
        "Do not use this product for more than 7 days unless directed by a dentist or healthcare provider"
      ],
      "stop_use": [
        "Stop use and see your physician promptly if swallowing, rash or fever develops; irritation, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "dosage_and_administration": [
        "Directions remove imprinted safety seal from bottle cap to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age and older Swish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Consult a dentist or healthcare provider"
      ],
      "dosage_and_administration_table": [
        "<table border=\"1\" cellspacing=\"12\" width=\"100%\"><tbody><tr><td><paragraph>Adults and children</paragraph><paragraph>2 years of age and older</paragraph></td><td/><td/><td>Swish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider</td></tr><tr><td>Children under 12 years of age</td><td/><td/><td>Should be supervised in the use of this product</td></tr><tr><td>Children under 2 years of age</td><td/><td/><td>Consult a dentist or healthcare provider</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other Information cap tightly keep away from heat or direct sunlight do not use if safety seal is broken or missing"
      ],
      "inactive_ingredient": [
        "alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, 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 RELIEVER BRAND FOR ADULTS With PAIN RELIEF! Orajel™ FOR ALL MOUTH SORES ANTISEPTIC RINSE Canker Sores Cheek Bites Gum Irritation Irritation from Dentures or Braces Promotes Healing Kills Bacteria Provides Pain Relief SOOTHING MINT RINSE ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER 16 FL OZ (473.2 mL) DA2011184_OJLBF-32499-06_72013522 10237-793 Back Label"
      ],
      "set_id": "06188d36-0d60-6ae6-e054-00144ff8d46c",
      "id": "45c2ec2f-1ee1-84f8-e063-6294a90ae393",
      "effective_time": "20251212",
      "version": "5",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Orajel Antiseptic Rinse For All Mouth Sores"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE AND MENTHOL"
        ],
        "manufacturer_name": [
          "Church & Dwight Co., Inc."
        ],
        "product_ndc": [
          "10237-760"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE",
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "2584344"
        ],
        "spl_id": [
          "45c2ec2f-1ee1-84f8-e063-6294a90ae393"
        ],
        "spl_set_id": [
          "06188d36-0d60-6ae6-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "10237-760-16",
          "10237-760-48"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BBX060AN9V",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}