{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity Sodium fluoride BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SACCHARIN SODIUM SORBITOL WATER SODIUM FLUORIDE FLUORIDE ION"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "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, see professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters 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 temperture"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water"
      ],
      "spl_unclassified_section": [
        "Tamper Evident Statement Sealed with printed neckband for your protection"
      ],
      "adverse_reactions": [
        "Adverse Reaction Visit us at: Rexall.com or call 1-866-4-REXALL DISTRIBUTED BY Old East Main CO, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc."
      ],
      "package_label_principal_display_panel": [
        "Principal display panel Since 1903 Rexall™ kids Anticavity Fluoride Rinse Anticavitvy Fluoride Rinse Helps prevent cavities Helps strengthen teeth Alcohol free IMPORTANT: read directions for proper use. ADA Accepted America Dental Association Helps Prevent cavities Bubblegum Flavor 500 mL (1.05 PT) 16.9 FL OZ image description image description"
      ],
      "set_id": "f8036e2e-7541-4922-92b9-0d8319f7b64c",
      "id": "4c0e8e2a-79a2-8052-e063-6294a90a4786",
      "effective_time": "20260302",
      "version": "27",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Old East Main Co."
        ],
        "product_ndc": [
          "55910-030"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "4c0e8e2a-79a2-8052-e063-6294a90a4786"
        ],
        "spl_set_id": [
          "f8036e2e-7541-4922-92b9-0d8319f7b64c"
        ],
        "package_ndc": [
          "55910-030-77",
          "55910-030-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}