{
  "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": [
        "botalab HERBAL COMPLETE TOOTH Sodium Fluoride CELLULOSE GUM GLYCERIN SODIUM FLUORIDE FLUORIDE ION SILICA SODIUM COCOYL GLUTAMATE LAURAMIDOPROPYL BETAINE SORBITOL XYLITOL WATER 2,3-BUTANEDIOL"
      ],
      "active_ingredient": [
        "Active ingredient(s) Sodium Fluoride 0.22% (0.10% w/w fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use(s) ■ Helps prevent cavities"
      ],
      "warnings": [
        "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. ■ If irritation of the mouth or gums occurs, discontinue use and consult a dentist or physician."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age"
      ],
      "dosage_and_administration": [
        "Directions ■ Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. ■ Children 2 to 6 years: Use only a pea-sized amount and supervise brushing to minimize swallowing. ■ Children under 2 years: Ask a dentist or physician."
      ],
      "other_safety_information": [
        "Other Information ■ This product contains 1,000 ppm fluoride. ■ Store at 20°–25°C (68°–77°F)."
      ],
      "questions": [
        "Questions +1-949-541-9431 riman.com"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Sorbitol, Water, Silica, Glycerin, Xylitol, Sodium Cocoyl Glutamate, Flavor, 2,3-Butanediol, Cellulose Gum, Lauramidopropyl Betaine, Stevia Rebaudiana Extract, Sodium Bicarbonate, Menthol, Sodium Chloride, p-Cymene, Butylene Glycol, Aloe Barbadensis Leaf Extract, Maltodextrin, Asiaticoside, Madecassic Acid, Asiatic Acid, Papain, Centella Asiatica Extract, Alcohol, Camellia Sinensis Leaf Extract, Eugenia Caryophyllus (Clove) Bud Oil, Salvia Officinalis (Sage) Extract, Daucus Carota Sativa (Carrot) Root Extract, Sodium Metabisulfite, Commiphora Myrrha Resin Extract, Potassium Sorbate, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Dextrin, Citric Acid, Lactic Acid"
      ],
      "package_label_principal_display_panel": [
        "Carton Image"
      ],
      "set_id": "51365ef7-ed94-2650-e063-6394a90ab89e",
      "id": "51365ef7-ed95-2650-e063-6394a90ab89e",
      "effective_time": "20260507",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "botalab HERBAL COMPLETE TOOTH"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "KMPHARMACEUTICAL CO., LTD."
        ],
        "product_ndc": [
          "50555-201"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "245598"
        ],
        "spl_id": [
          "51365ef7-ed95-2650-e063-6394a90ab89e"
        ],
        "spl_set_id": [
          "51365ef7-ed94-2650-e063-6394a90ab89e"
        ],
        "package_ndc": [
          "50555-201-01",
          "50555-201-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}