{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Willo Bubble Twist Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BENZOATE CALCIUM CITRATE STEVIOSIDE SODIUM BICARBONATE SODIUM COCOYL GLUTAMATE WATER SUCRALOSE SORBITOL GLYCERIN YEAST .BETA.-D-GLUCAN MENTHOL CITRIC ACID SODIUM ASCORBYL PHOSPHATE PEG-400"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredient Sodium Fluoride 0.22% (0.10% w/v Fluoride Ion)"
      ],
      "purpose": [
        "Purpose Section Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Section Use Aids in the prevention of dental cavities"
      ],
      "keep_out_of_reach_of_children": [
        "Warnings Keep out of reach of children under 6 years of age, without adult supervision. 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 under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing). Supervise as necessary until capable of using without supervision children under 2 years of age consult a dentist or doctor."
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph>adults and</paragraph><paragraph>children 2 years</paragraph><paragraph>of age and older</paragraph></td><td><paragraph>brush teeth thoroughly, preferably</paragraph><paragraph>after each meal or at least twice a</paragraph><paragraph>day, or as directed by a dentist or</paragraph><paragraph>doctor</paragraph></td></tr><tr><td><paragraph>children under 6</paragraph><paragraph>years of age</paragraph></td><td><paragraph/><paragraph>instruct in good brushing and</paragraph><paragraph>rinsing habits (to minimize swallowing). Supervise as</paragraph><paragraph>necessary until capable of using</paragraph><paragraph>without supervision</paragraph></td></tr><tr><td><paragraph>children under 2</paragraph><paragraph>years of age</paragraph></td><td><paragraph/><paragraph>consult a dentist or doctor.</paragraph></td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Citric Acid, Flavor, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Stevioside, Sodium Ascorbyl Phosphate, Menthol, Calcium Citrate"
      ],
      "questions": [
        "Questions or comments? Tel: 1(888) 509-0459 or Email: support@willo.com Visit us at willo.com Distributed by: Willo 32, Inc. New York NY 10016 Willo.com"
      ],
      "spl_unclassified_section": [
        "Flavor description BUBBLEGUM FLAVOR",
        "Free of claims Dye free SLS free Sulfate free Paraben free Gluten free",
        "Distributor name and address Dist. by: Willo 32, Inc New York, NY 10006 1 (888) 509-0459"
      ],
      "warnings": [
        "Broken seal warning Do not use if seal under cap is broken or missing."
      ],
      "package_label_principal_display_panel": [
        "Willo Bubble Twist 8 oz Label Willo Bubble Twist Anticavity Fluoride Liquid Toothpaste Helps Prevent Cavities & Strengthens Enamel 8 fl oz (237 ml)",
        "Label images 8 oz Label Willo Two 2 oz Box Willo 2 oz Interior Label"
      ],
      "set_id": "36560d62-e901-1f93-e063-6394a90a2803",
      "id": "58b2fffb-7709-3f24-e063-6294a90ab105",
      "effective_time": "20260810",
      "version": "3",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Willo Bubble Twist"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Willo 32 Inc"
        ],
        "product_ndc": [
          "84185-102"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "245598"
        ],
        "spl_id": [
          "58b2fffb-7709-3f24-e063-6294a90ab105"
        ],
        "spl_set_id": [
          "36560d62-e901-1f93-e063-6394a90a2803"
        ],
        "package_ndc": [
          "84185-102-08",
          "84185-102-02",
          "84185-102-22"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850036633136",
          "0850036633785"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}