{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  "results": [
    {
      "spl_product_data_elements": [
        "Koala Pals Berrylicious Sodium Fluoride ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM GLYCERIN HYDRATED SILICA POTASSIUM SORBATE SODIUM BENZOATE SODIUM BICARBONATE SODIUM LAUROYL SARCOSINATE SORBITOL WATER XANTHAN GUM XYLITOL SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of cavities"
      ],
      "keep_out_of_reach_of_children": [
        "Warnings Keep out of reach of children under 6 years 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 years of age and older: brush teeth thoroughly, preferably after each meal, or at least twice a day or as directed by a dentist or doctor children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years of age: ask a dentist or doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol"
      ],
      "warnings": [
        "Warnings"
      ],
      "package_label_principal_display_panel": [
        "image of label"
      ],
      "set_id": "6624be86-c9a8-53b8-e053-2a91aa0a87ef",
      "id": "4746e0a5-a9c5-c828-e063-6394a90ada98",
      "effective_time": "20251231",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Koala Pals Berrylicious"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Melaleuca, Inc."
        ],
        "product_ndc": [
          "54473-300"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "4746e0a5-a9c5-c828-e063-6394a90ada98"
        ],
        "spl_set_id": [
          "6624be86-c9a8-53b8-e053-2a91aa0a87ef"
        ],
        "package_ndc": [
          "54473-300-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}