{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "EUTHYMOL WHITENING GIFT SET (40gX3) Sodium Fluoride EUTHYMOL WHITENING Sodium Fluoride XANTHAN GUM GLYCERIN THYMOL COCAMIDOPROPYL BETAINE SUCRALOSE POTASSIUM PHOSPHATE, TRIBASIC .ALPHA.-TOCOPHEROL ACETATE EUCALYPTUS GLOBULUS LEAF SODIUM FLUORIDE FLUORIDE ION ALGIN POLOXAMER 407 ZINC STEARATE YELLOW 6 POTASSIUM PHOSPHATE TITANIUM DIOXIDE SODIUM SACCHARIN SODIUM LAURYL SULFATE RED 33 PEG-6 HYDRATED SILICA CARRAGEENAN SODIUM HEXAMETAPHOSPHATE WATER"
      ],
      "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": [
        "40g CARTON CARTON Back"
      ],
      "set_id": "369aa02f-c312-6a0d-e063-6294a90adaa5",
      "id": "369a9de7-e8e9-4562-e063-6394a90ae245",
      "effective_time": "20250522",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "EUTHYMOL WHITENING GIFT SET (40gX3)"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "LG HOUSEHOLD & HEALTH CARE LTD."
        ],
        "product_ndc": [
          "53208-573"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "369a9de7-e8e9-4562-e063-6394a90ae245"
        ],
        "spl_set_id": [
          "369aa02f-c312-6a0d-e063-6294a90adaa5"
        ],
        "package_ndc": [
          "53208-573-00",
          "53208-566-43",
          "53208-566-46"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "8809949561298"
        ]
      }
    }
  ]
}