{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Oral Sore Antiseptic Hydrogen Peroxide, Menthol ALCOHOL FD&C BLUE NO. 1 EDETATE DISODIUM ANHYDROUS METHYL SALICYLATE PHOSPHORIC ACID POLOXAMER 338 POLYSORBATE 20 SACCHARIN SODIUM SORBITOL WATER HYDROGEN PEROXIDE HYDROGEN PEROXIDE MENTHOL MENTHOL"
      ],
      "active_ingredient": [
        "active ingredients Hydrogen peroxide 1.5% (w/v) Menthol 0.1% (w/v)"
      ],
      "purpose": [
        "purpose Oral debriding agent/Oral antiseptic Oral pain reliever"
      ],
      "indications_and_usage": [
        "uses first aid to help protect against bacterial contamination in minor oral wounds for temporary pain relief and temporary use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures dentures orthodontic appliances accidental injury other irritations of the mouth and gums canker sores aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth"
      ],
      "warnings": [
        "warnings for this product"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting irritation, pain, or redness persists or worsens swelling, rash, or fever develops sore mouth symptoms do not improve in 7 days"
      ],
      "when_using": [
        "When using this product do not swallow do not use more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage"
      ],
      "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 Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician Children under 12 years of age - should be supervised in the use of the product Children under 2 years of age - consult a dentist or doctor"
      ],
      "other_safety_information": [
        "other information store at controlled room temperature 68-77°F (20-25°C) keep away from heat or direct sunlight"
      ],
      "inactive_ingredient": [
        "inactive ingredients alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water"
      ],
      "spl_unclassified_section": [
        "Disclaimer *This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse for all Mouth Sores."
      ],
      "adverse_reactions": [
        "ADVERSE REACTION SATISFACTION GUARANTEE If you're not satisfed, we'll happily refund your money. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "principal display panel Sealed with printed neckband for your protection Compare to Orajel™ Antiseptic Rinse for all Mouth Sores* ORAL SORE ANTISEPTIC RINSE TEMPORARY PAIN RELIEF FOR MOUTH SORES MINT for mouth sores, including gum irritation from braces or dentures and canker sores kills germs and bacteria helps alleviate pain 473 mL (16 FL OZ) image description image description"
      ],
      "set_id": "e67046ce-bfe0-4454-bbe8-6a3783afb6f5",
      "id": "499edc10-3e99-6a7b-e063-6394a90a0fee",
      "effective_time": "20260130",
      "version": "7",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Oral Sore Antiseptic"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE, MENTHOL"
        ],
        "manufacturer_name": [
          "Rite Aid Corporation"
        ],
        "product_ndc": [
          "11822-3024"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE",
          "MENTHOL"
        ],
        "spl_id": [
          "499edc10-3e99-6a7b-e063-6394a90a0fee"
        ],
        "spl_set_id": [
          "e67046ce-bfe0-4454-bbe8-6a3783afb6f5"
        ],
        "package_ndc": [
          "11822-3024-4"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BBX060AN9V",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}