{
  "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": [
        "Firefly Anticavity Fluoride sodium fluoride SODIUM FLUORIDE FLUORIDE ION CETYLPYRIDINIUM CHLORIDE CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS FD&C BLUE NO. 1 MENTHOL, UNSPECIFIED FORM POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE XYLITOL"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.05%"
      ],
      "purpose": [
        "Purpose Anticavity rinse"
      ],
      "indications_and_usage": [
        "Use 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 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 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."
      ],
      "other_safety_information": [
        "Other Information • recommended storage temperature 59°-86°F(15°-30°C) • do not use if printed plastic neckband is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, FD&C blue#1, flavor, menthol, poloxamer 407, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol"
      ],
      "questions": [
        "Questions? Toll Free: 1-866-373-7374"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel FIREFLY™ ANTICAVITY Fluoride Rinse PAW PATROL™ BUBBLE GUM nickelodeon ™ Helps PREVENT CAVITIES ADA Accepted American Dental Association Helps prevent cavities Alcohol FREE IMPORTANT: Read directions for proper use. 16 FL OZ (473 mL) firefly-anticavity-fluoride-rinse-front firefly-anticavity-fluoride-rinse-back"
      ],
      "set_id": "e91ed8a1-0d45-402c-9c16-1ae72e695a37",
      "id": "bcec5748-5675-4b7b-b844-2ffbac08e719",
      "effective_time": "20241120",
      "version": "2",
      "openfda": {
        "application_number": [
          "M008"
        ],
        "brand_name": [
          "Firefly Anticavity Fluoride"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Ranir LLC"
        ],
        "product_ndc": [
          "66923-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "bcec5748-5675-4b7b-b844-2ffbac08e719"
        ],
        "spl_set_id": [
          "e91ed8a1-0d45-402c-9c16-1ae72e695a37"
        ],
        "package_ndc": [
          "66923-003-43",
          "66923-003-34"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}