{
  "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": [
        "sodium fluoride rinse sodium fluoride rinse WATER EUCALYPTOL SPEARMINT OIL PHOSPHORIC ACID METHYL SALICYLATE MENTHOL, UNSPECIFIED FORM SACCHARIN SODIUM DISODIUM PHOSPHATE SUCRALOSE SODIUM FLUORIDE FLUORIDE ION FD&C RED NO. 40 FD&C BLUE NO. 1 SODIUM LAURYL SULFATE THYMOL PROPYLENE GLYCOL POLOXAMER 407 SORBITOL MENTHA PIPERITA (PEPPERMINT) OIL SODIUM BENZOATE"
      ],
      "spl_unclassified_section": [
        "Tamper Evident Statement Sealed with printed neckband for your protection.",
        "Disclaimer *This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash."
      ],
      "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 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"
      ],
      "other_safety_information": [
        "Other information store at controlled room temperature 20°-25°C (68°–77° 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"
      ],
      "questions": [
        "Questions or comments? Call 877-757-5005"
      ],
      "adverse_reactions": [
        "Adverse Reactions Distributed by: Rockland Cosmetics, Inc. Hillburn, NY 10931 www.RocklandCosmetics.com Made in the U.S.A. with U.S. and foreign components. NSK New Square Kashrus"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel COMPARE TO LISTERINE ® ZERO ALCOHOL* mint'evo EVOLUTIONIZING ORAL FRESHNESS FLUORIDE ANTI-CAVITY MOUTHWASH SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION ALCOHOL FREE HELPS STRENGTHEN TEETH TO FIGHT CAVITIES FRESHENS BREATH FRESH MINT IMPORTANT: READ DIRECTIONS FOR PROPER USE. 1 L (1.05 QT) 33.8 FL OZ mm01 mm02"
      ],
      "set_id": "52430b12-4d5f-d1e1-e063-6394a90abd64",
      "id": "52430b12-4d60-d1e1-e063-6394a90abd64",
      "effective_time": "20260520",
      "version": "1",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "sodium fluoride rinse"
        ],
        "generic_name": [
          "SODIUM FLUORIDE RINSE"
        ],
        "manufacturer_name": [
          "Rockland Cosmetics, Inc."
        ],
        "product_ndc": [
          "69892-971"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM FLUORIDE"
        ],
        "rxcui": [
          "313029"
        ],
        "spl_id": [
          "52430b12-4d60-d1e1-e063-6394a90abd64"
        ],
        "spl_set_id": [
          "52430b12-4d5f-d1e1-e063-6394a90abd64"
        ],
        "package_ndc": [
          "69892-971-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8ZYQ1474W7"
        ]
      }
    }
  ]
}