{
  "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": [
        "Anticavity Fluoride Rinse Sodium Fluoride WATER SORBITOL MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE CETYLPYRIDINIUM CHLORIDE SACCHARIN SODIUM POLOXAMER 407 POLYSORBATE 20 PROPYLENE GLYCOL SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS EDETATE CALCIUM DISODIUM ANHYDROUS EDETATE DISODIUM SODIUM BENZOATE POTASSIUM SORBATE BENZYL ALCOHOL FD&C GREEN NO. 3 FD&C YELLOW NO. 5 SODIUM FLUORIDE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Tamper Evident Statement Sealed with printed neckband for your protection",
        "Disclaimer *This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash"
      ],
      "active_ingredient": [
        "Active ingredient Sodium Fluoride 0.05% (0.02% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity Rinse"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warning for this product only"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "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"
      ],
      "storage_and_handling": [
        "other information store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5"
      ],
      "questions": [
        "Questions? Call 1-888-593-0593"
      ],
      "adverse_reactions": [
        "Adverse reactions MADE WTH PRIDE AND CARE FOR H-E-B ® , SAN ANTONIO, TX 78204 100% Guarantee promise ADA Accepted American Dental Association ® Helps prevent cavitites PLASTIC BOTTLE US ONLY Widely Recyclable Discard Seal, Empty & Replace Cap"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Compare to ACT ® Anticavity Fluoride Mouthwash* H-E-B ® ANTICAVITY ANTICAVITY FLUORIDE RINSE Helps Prevent Cavities Alcohol Free Freshens Breath MINT IMPORTANT: read directions for proper use. ADA Accepted American Dental Association ® 18 FL OZ (1.12 PT) 532 mL image description image description"
      ],
      "set_id": "c68b0644-685d-4c62-bf5d-3a5bbea3b052",
      "id": "54dc850a-bab8-5379-e063-6294a90a51d6",
      "effective_time": "20260622",
      "version": "5",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "Anticavity Fluoride Rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "37808-213"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "240698"
        ],
        "spl_id": [
          "54dc850a-bab8-5379-e063-6294a90a51d6"
        ],
        "spl_set_id": [
          "c68b0644-685d-4c62-bf5d-3a5bbea3b052"
        ],
        "package_ndc": [
          "37808-213-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}