{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Burts Bees Extra White Sodium Fluoride SODIUM LAURYL GLYCOL CARBOXYLATE CARRAGEENAN TITANIUM DIOXIDE XANTHAN GUM WATER HYDRATED SILICA GLYCERIN STEVIA REBAUDIANA WHOLE SODIUM FLUORIDE FLUORIDE ION LAURYL GLUCOSIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "*Peppermint Oil and other Natural Flavor",
        "DISTR. BY SUNFLOWER DISTRIBUTING LLC, CINCINNATI, OH 45202"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.243% (0.13% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity toothpaste"
      ],
      "indications_and_usage": [
        "Use helps protect against cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 yrs of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 yrs of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed 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 yrs.: ask a dentist"
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, water, hydrated silica, flavor*, sodium lauryl glucose carboxylate, xanthan gum, lauryl glucoside, carrageenan, stevia rebaudiana extract, titanium dioxide"
      ],
      "questions": [
        "Questions? 1-855-248-5352"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 133 g tube in carton IMPROVED FORMULA BURT'S BEES ® Extra White FLUORIDE TOOTHPASTE prevents cavities removes stains protects enamel ADA Accepted American Dental Association Mountain Mint NOT TESTED ON ANIMALS Madewithout SLS, artificial flavors & sweeteners NET WT 4.7 OZ (133 g) label"
      ],
      "set_id": "c92524fd-8b93-592d-e053-2a95a90a88c6",
      "id": "51b86222-3b3e-1b41-e063-6294a90a4013",
      "effective_time": "20260513",
      "version": "9",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Burts Bees Extra White"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Procter & Gamble Manufacturing Company"
        ],
        "product_ndc": [
          "69423-962"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "891775"
        ],
        "spl_id": [
          "51b86222-3b3e-1b41-e063-6294a90a4013"
        ],
        "spl_set_id": [
          "c92524fd-8b93-592d-e053-2a95a90a88c6"
        ],
        "package_ndc": [
          "69423-962-47",
          "69423-962-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}