{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Eversmile OrthoFoam Anticavity 0.05% Sodium Fluoride Rinse SODIUM FLUORIDE FLUORIDE ION WATER HYDROGEN PEROXIDE PVP POLYETHYLENE GLYCOL, UNSPECIFIED GLYCERIN SUCRALOSE SODIUM LAURYL SULFATE SODIUM CITRATE SODIUM BENZOATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride....... 0.05% (0.02% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Uses •aids in the prevention of dental cavities"
      ],
      "warnings": [
        "​ ​Warnings ​Stop use and ask dentist if ​oral irritation or tooth sensitivity occurs"
      ],
      "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: To Brush: •Dispense 1-2 pumps of foam onto a toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician EverSmile Traybrush application: •Adults and children 12 yrs. of age and older: •Dispense 1-2 pumps of foam onto each side of the TrayBrush. •Insert the foam-filled Traybrush into your mouth. Gently bite up and down, and move the handle side to side for approximately 2 minutes to clean. •If needed, remove the TrayBrush to spit out excess foam- do not swallow, then reinsert it immediately. •Option: after brushing keep the TrayBrush in contact with your teeth for up to 5 minutes to enhance the therapeutic benefits. •Use daily or as directed by your dentist. •Children under 12 years of age: consult a dentist or doctor"
      ],
      "other_safety_information": [
        "Other information store at controlled room temperature 68-77°F(20-25°)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, hydrogen peroxide, PVP, PEG, glycerin, sucralose, sodium lauryl sulfate, natural bubble gum flavor, sodium citrate, sodium benzoate"
      ],
      "questions": [
        "​Questions? + ​1(855)595-2999"
      ],
      "package_label_principal_display_panel": [
        "EverSmile ® ORTHOFOAM ANTICAVITY BRACES CLEANING FOAM Labelinh ------------------------------------------ EverSmile ​® ​ORTHOFOAM ANTICAVITY BRACES CLEANING FOAM Bubble gum​ ​0.05% Sodium Fluoride 50 mL (1.69 fl oz) Manufactured By EverBrands, Inc 11791 Monarch St Garden Grove, CA 92841 (855)595-2999 info@eversmilewhite.com eversmilewhite.com RES outer package Inner package"
      ],
      "set_id": "9c12e792-94c8-4e29-9a54-e7e70aadade6",
      "id": "cb1b1057-9f4f-4ff3-ab9c-b150261dc39a",
      "effective_time": "20260416",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Eversmile OrthoFoam Anticavity"
        ],
        "generic_name": [
          "0.05% SODIUM FLUORIDE RINSE"
        ],
        "manufacturer_name": [
          "Everbrands, Inc."
        ],
        "product_ndc": [
          "72655-600"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "2597250"
        ],
        "spl_id": [
          "cb1b1057-9f4f-4ff3-ab9c-b150261dc39a"
        ],
        "spl_set_id": [
          "9c12e792-94c8-4e29-9a54-e7e70aadade6"
        ],
        "package_ndc": [
          "72655-600-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0810055330348"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}