{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Hismile Strawberry Flavor Sodium Fluoride Anticavity Toothpaste D&C RED NO. 33 WATER SODIUM FLUORIDE FLUORIDE ION SODIUM LAUROYL SARCOSINATE HYDRATED SILICA GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CAPRYLYL GLYCOL PENTYLENE GLYCOL METHYL DIISOPROPYL PROPIONAMIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SORBITOL ZINC LACTATE XANTHAN GUM BENZYL ALCOHOL BENZOIC ACID SUCRALOSE XYLITOL POTASSIUM PYROPHOSPHATE SODIUM GLUCONATE"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.24% (0.14% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warinings Warnings When using this product do not swallow do not use in eye area Keep out of reach of children under 6 years of age 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."
      ],
      "when_using": [
        "When using this product do not swallow do not use in eye area"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age 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 ange and older：Brush teeth thoroughly preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). supervise children as necessary until capable of using without supervision. children under 2 years of age: Consult a dentist or doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No. 33"
      ],
      "spl_unclassified_section": [
        "Other information Strawberry Flavor Sodium Fluoride Anticavity Toothpaste Manufactured for: Hismile Pty Ltd, 225 Burleigh Connection Rd, Burleigh Waters, Queensland, Australia 4220. Formulated in Australia. Made in USA. www.hismileteeth.com © Hismile Pty Ltd, 2022 TRUSTED BY DENTISTS sugar-free cruelty- free no SLS & PEGs vegan Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience."
      ],
      "package_label_principal_display_panel": [
        "label label label"
      ],
      "set_id": "0ef766ae-754a-f185-e063-6294a90a3299",
      "id": "4878e7f3-6f6e-77be-e063-6394a90a9d8e",
      "effective_time": "20260115",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Hismile"
        ],
        "generic_name": [
          "STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE"
        ],
        "manufacturer_name": [
          "Hismile Pty Ltd"
        ],
        "product_ndc": [
          "83013-318"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "416783"
        ],
        "spl_id": [
          "4878e7f3-6f6e-77be-e063-6394a90a9d8e"
        ],
        "spl_set_id": [
          "0ef766ae-754a-f185-e063-6294a90a3299"
        ],
        "package_ndc": [
          "83013-318-06"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}