{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Anticavity Sodium Fluoride WATER SORBITOL PROPYLENE GLYCOL POLOXAMER 407 SODIUM LAURYL SULFATE SODIUM BENZOATE PHOSPHORIC ACID EUCALYPTOL METHYL SALICYLATE THYMOL SACCHARIN SODIUM MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUCRALOSE SPEARMINT OIL PEPPERMINT OIL FD&C RED NO. 40 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% (0.01% 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 daily after brushing your teeth with a toothpaste vigorously swish 10 mL of rinse between your teeth for 1 miute 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"
      ],
      "storage_and_handling": [
        "Other information store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F) cold weather may temporarily cloud this product"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1"
      ],
      "spl_unclassified_section": [
        "Disclaimer Since 1903 Rexall ® is a registered trademark of Rexall Sundown, Inc. *This product is not intended to replace brushing or flossing"
      ],
      "adverse_reactions": [
        "Adverse Reaction 100% Satisfaction Guaranteed If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied. (888)309-9030 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072"
      ],
      "package_label_principal_display_panel": [
        "principal panel display Since 1903 Rexall™ Fluoride Anti-Cavity Mouthwash Sodium Fluoride and Acidulated Phosphate Topical Solution Alcohol-Free 6 BENEFITS Freshens breath Restores enamel Helps strengthen teeth to fight cavities Kills bad breath germs Burn free Cleans the entire mouth* IMPORTANT: read directions for proper use. FRESH MINT 1 L (1.05 QT) 33.8 FL OZ image description image description"
      ],
      "set_id": "c7b9e9cd-3cf7-4657-83c9-e221e1c35977",
      "id": "4c10bc9a-52b8-fbf2-e063-6394a90a5780",
      "effective_time": "20260302",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "Old East Main Co."
        ],
        "product_ndc": [
          "55910-971"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "4c10bc9a-52b8-fbf2-e063-6394a90a5780"
        ],
        "spl_set_id": [
          "c7b9e9cd-3cf7-4657-83c9-e221e1c35977"
        ],
        "package_ndc": [
          "55910-971-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}