{
  "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"
      ],
      "storage_and_handling": [
        "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"
      ],
      "adverse_reactions": [
        "ADVERSE REACTION DISTRIBUTED BY ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. *This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores. DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel CAREONE Compare to Orajel Antispetic Rinse Mouth Sores* ORAL SORE ANTISEPTIC RINSE ORAL PAIN RELIEVER ORAL DEBRIDING AGENT FOR MOUTH SORES, INCLUDING GUM IRRITATION FROM BRACES OR DENTURES AND CANKER SORES MINT FLAVOR Sealed With Printed Neckband For Your Protection NET 16 FL OZ (1 PT) 473 mL image description"
      ],
      "set_id": "d46546d0-c6df-431a-8ab0-bc5013c084d7",
      "id": "4a2a92e5-2777-17b9-e063-6394a90af80c",
      "effective_time": "20260206",
      "version": "6",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Oral Sore Antiseptic"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE, MENTHOL"
        ],
        "manufacturer_name": [
          "Retail Business Services, LLC"
        ],
        "product_ndc": [
          "72476-024"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE",
          "MENTHOL"
        ],
        "rxcui": [
          "2584344"
        ],
        "spl_id": [
          "4a2a92e5-2777-17b9-e063-6394a90af80c"
        ],
        "spl_set_id": [
          "d46546d0-c6df-431a-8ab0-bc5013c084d7"
        ],
        "package_ndc": [
          "72476-024-43"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BBX060AN9V",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}