{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity Sodium fluoride WATER ALCOHOL HYDROGEN PEROXIDE POLOXAMER 407 SACCHARIN SODIUM SUCRALOSE MENTHOL PHOSPHORIC ACID SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active Ingredient Sodium fluoride 0.02% (0.01% w/v fluoride ion) Purpose Anticavity"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings For this product"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature (59º-77ºF)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor"
      ],
      "spl_unclassified_section": [
        "Disclaimer Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened."
      ],
      "adverse_reactions": [
        "Adverse Reactions DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 1-833-992-3872 Quality Guaranteed or your money back. DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "principal display panel CAREONE ® ADVANCED WHITENING ANTICAVITY MOUTHRINSE 5 DAYS TO WHITER TEETH BEGINS WORKING ON CONTACT SAFELY WHITENS TEETH KILLS GERMS THAT CAUSE BAD BREATH FRESH MINT FLAVOR Sealed With Printed Neckband For Your Protection IMPORTANT: Read directions for proper use. 32 FL OZ (1 QT) 946 mL image description image description"
      ],
      "set_id": "cf0c8b48-0d1c-406a-a67d-7d16187d38d8",
      "id": "4ee28734-6642-0853-e063-6394a90a1bd7",
      "effective_time": "20260407",
      "version": "16",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "ADUSA Distribution, LLC"
        ],
        "product_ndc": [
          "72476-435"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "4ee28734-6642-0853-e063-6394a90a1bd7"
        ],
        "spl_set_id": [
          "cf0c8b48-0d1c-406a-a67d-7d16187d38d8"
        ],
        "package_ndc": [
          "72476-435-45",
          "72476-435-43"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}