{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "EUTHYMOL WHITENING SET Sodium Fluoride Euthymol Whitening Sodium Fluoride ALGIN XANTHAN GUM GLYCERIN RED 33 YELLOW 6 POTASSIUM PHOSPHATE SODIUM FLUORIDE FLUORIDE ION TITANIUM DIOXIDE THYMOL POLOXAMER 407 ZINC STEARATE COCAMIDOPROPYL BETAINE CARRAGEENAN SUCRALOSE POTASSIUM PHOSPHATE, TRIBASIC SODIUM HEXAMETAPHOSPHATE PEG-6 HYDRATED SILICA SODIUM SACCHARIN .ALPHA.-TOCOPHEROL ACETATE EUCALYPTUS GLOBULUS LEAF WATER SODIUM LAURYL SULFATE Euthymol Whitening Sodium Fluoride ALGIN XANTHAN GUM GLYCERIN RED 33 YELLOW 6 POTASSIUM PHOSPHATE SODIUM FLUORIDE FLUORIDE ION TITANIUM DIOXIDE THYMOL POLOXAMER 407 WATER ZINC STEARATE COCAMIDOPROPYL BETAINE CARRAGEENAN SUCRALOSE POTASSIUM PHOSPHATE, TRIBASIC SODIUM HEXAMETAPHOSPHATE PEG-6 HYDRATED SILICA SODIUM SACCHARIN .ALPHA.-TOCOPHEROL ACETATE EUCALYPTUS GLOBULUS LEAF SODIUM LAURYL SULFATE"
      ],
      "active_ingredient": [
        "Active Ingredients Sodium Fluoride 0.243% (0.15% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity toothpaste"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Keep out of reach of children Keep out of reach of children under 6 years of age. Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children under 6 years of age."
      ],
      "dosage_and_administration": [
        "Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately."
      ],
      "instructions_for_use": [
        "Directions adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist. do not swallow. to minimize swallowing use a pea-sized amount in children under 6. supervise children's brushing until good habits are established. children under 2 years: ask a dentist"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol"
      ],
      "questions": [
        "Questions? 1-866-993-4709"
      ],
      "package_label_principal_display_panel": [
        "CARTON CARTON"
      ],
      "set_id": "35839b10-4c40-40e5-e063-6294a90a85b4",
      "id": "358399ee-bc12-06a1-e063-6394a90a9d96",
      "effective_time": "20250519",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "EUTHYMOL WHITENING SET"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "LG HOUSEHOLD & HEALTH CARE LTD."
        ],
        "product_ndc": [
          "53208-568"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "358399ee-bc12-06a1-e063-6394a90a9d96"
        ],
        "spl_set_id": [
          "35839b10-4c40-40e5-e063-6294a90a85b4"
        ],
        "package_ndc": [
          "53208-568-00",
          "53208-566-63",
          "53208-566-65",
          "53208-566-73",
          "53208-566-75"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "8809949563926"
        ]
      }
    }
  ]
}