{
  "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": [
        "ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER ALCOHOL SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS FD&C BLUE NO. 1 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information do not use if safety seal is broken or missing"
      ],
      "active_ingredient": [
        "Active ingredients 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 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 remove cap pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark 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"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1 (245-167) www.actfluoride.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORI NG ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 18 fl oz (532 mL) #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL MINT 18 fl oz (532 mL)"
      ],
      "set_id": "ef63e193-5804-4b35-bae7-cad29cf4e8bc",
      "id": "e957eb42-3732-49b1-93e2-456b5f9a9447",
      "effective_time": "20260112",
      "version": "11",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "ACT Restoring Anticavity Fluoride Cool Mint"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Chattem, Inc."
        ],
        "product_ndc": [
          "41167-0957"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698",
          "656809"
        ],
        "spl_id": [
          "e957eb42-3732-49b1-93e2-456b5f9a9447"
        ],
        "spl_set_id": [
          "ef63e193-5804-4b35-bae7-cad29cf4e8bc"
        ],
        "package_ndc": [
          "41167-0957-5"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}