{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity Fluoride Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL PROPYLENE GLYCOL POLOXAMER 407 BENZYL ALCOHOL DISODIUM PHOSPHATE SODIUM BENZOATE SODIUM SACCHARIN POLYSORBATE 80 CETYLPYRIDINIUM CHLORIDE CALCIUM DISODIUM EDTA D&C RED NO. 33 SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM"
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity rinse"
      ],
      "indications_and_usage": [
        "Uses aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "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 (1-800-222-1222) right away."
      ],
      "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"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature do not use if safety seal is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33"
      ],
      "questions": [
        "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse* Children's ANTICAVITY FLUORIDE RINSE 6+ YEARS Sodium Fluoride 0.05% Help prevent cavities Alcohol Free IMPORTANT: Read directions for proper use. BUBBLEGUM FLAVOR TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse DISTRIBUTED BY: MIDWOOD BRANDS, LLC 510 VOLVO PKWY, CHESAPEAKE, VA 23320",
        "Package label FAMILY WELLNESS Children's Anticavity Fluoride Rinse BubbleGum Flavor Sodium fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "set_id": "63c4c0e9-84b1-4076-bdf4-7e9543b2cf46",
      "id": "55150efe-465e-4f46-ab4e-c75b2b085a46",
      "effective_time": "20260401",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity Fluoride"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Family Dollar (FAMILY WELLNESS)"
        ],
        "product_ndc": [
          "55319-807"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "spl_id": [
          "55150efe-465e-4f46-ab4e-c75b2b085a46"
        ],
        "spl_set_id": [
          "63c4c0e9-84b1-4076-bdf4-7e9543b2cf46"
        ],
        "package_ndc": [
          "55319-807-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0032251773815"
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}