{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity Sodium fluoride WATER ALCOHOL 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"
      ],
      "other_safety_information": [
        "Tamper Evident Statement Sealed with printed neckband for your protection"
      ],
      "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"
      ],
      "questions": [
        "Questions? Call 1-888-287-1915"
      ],
      "adverse_reactions": [
        "Adverse reaction Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915. DISTRIBUTED BY: Walmart, Inc., Bentonville, AR 72716 Discard Seal, Empty & Replace Cap PLASTIC BOTTLE how2recycle.info Made in the USA with domestic and imported ingredients Factory Certified DSP-TN-21091 DSP-MO-20087"
      ],
      "spl_unclassified_section": [
        "Disclaimer *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Act Restoring ® Anticavity Fluoride Mouthwash Cool Mint."
      ],
      "package_label_principal_display_panel": [
        "Principal panel display equate ™ NDC 49035-581-86 Compare to Act Restoring ® Anticavity Fluoride Mouthwash Coll Mint active ingredient* Restoring Anticavity Fluoride Mouthwash Refreshing Mint Restores enamel Helps remineralize soft spots IMPORTANT: read directions for proper use. 33.8 FL OZ (1.05 QT) 1 L image description image description"
      ],
      "set_id": "af5b93e7-5cce-4e01-8df2-54494d8b2910",
      "id": "4bd50069-b71a-f46e-e063-6294a90a93f9",
      "effective_time": "20260227",
      "version": "16",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Walmart Inc."
        ],
        "product_ndc": [
          "49035-581"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "4bd50069-b71a-f46e-e063-6294a90a93f9"
        ],
        "spl_set_id": [
          "af5b93e7-5cce-4e01-8df2-54494d8b2910"
        ],
        "package_ndc": [
          "49035-581-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}