{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sodium fluoride Sodium fluoride SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM CETYLPYRIDINIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE CALCIUM DISODIUM ANHYDROUS FD&C BLUE NO. 1 SODIUM FLUORIDE FLUORIDE ION WATER ALCOHOL"
      ],
      "spl_unclassified_section": [
        "Claims Leaves your entire mouth feeling clean while it helps strengthen teeth and prevent tooth decay."
      ],
      "active_ingredient": [
        "Active ingredient Sodium fluoride 0.02% (0.009% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use Aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warning 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"
      ],
      "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"
      ],
      "adverse_reactions": [
        "Adverse reaction *This product is not manufactured or distributed by Chattem Inc., distributor of Act ® Restoring Anticavity Mouthwash Cool Mint DSP-TN-21091 DSP-MO-20087 DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC. 875 EAST STREET TEWKSBURY, MA 01876"
      ],
      "package_label_principal_display_panel": [
        "Principal Panel Display Sealed With Printed Neckband For Your Protection MARKET BASKET ® \"MORE FOR YOUR DOLLAR\" Compare to Act ® Restoring Anticavity Fluoride Mouthwash* Restoring Anticavity Fluoride Mouthwash ANTICAVITY MOUTHWASH Refreshing Mint Restores enamel Helps avoid tooth decay Helps remineralize soft spots Freshens breath IMPORTANT: read directions for proper use. 33.8 FL OZ (1 L) image description image description"
      ],
      "set_id": "2f5d3c75-1a11-47e1-b297-e2302177efe7",
      "id": "49f0f3e2-248d-abb3-e063-6394a90aef6f",
      "effective_time": "20260203",
      "version": "4",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Sodium fluoride"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Demoulas Super Markets, Inc"
        ],
        "product_ndc": [
          "53942-581"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "49f0f3e2-248d-abb3-e063-6394a90aef6f"
        ],
        "spl_set_id": [
          "2f5d3c75-1a11-47e1-b297-e2302177efe7"
        ],
        "package_ndc": [
          "53942-581-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}