{
  "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": [
        "Listerine Essential Care Sodium Monofluorophosphate WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 1600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED SACCHARIN SODIUM EUCALYPTOL METHYL SALICYLATE THYMOL PHOSPHORIC ACID MENTHOL, UNSPECIFIED FORM SODIUM PHOSPHATE XANTHAN GUM BENZOIC ACID SPEARMINT OIL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 D&C YELLOW NO. 10 SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Kenvue Brands LLC, Summit, NJ 07901"
      ],
      "active_ingredient": [
        "Active ingredient Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)"
      ],
      "purpose": [
        "Purpose Anticavity"
      ],
      "indications_and_usage": [
        "Use aids in the prevention of dental cavities"
      ],
      "warnings": [
        "Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician. children 2-6 years use a pea sized amount instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. children under 2 years of age: ask a dentist or doctor"
      ],
      "storage_and_handling": [
        "Other information Store at Room Temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10"
      ],
      "questions": [
        "Questions? call toll-free 888-222-0182 or 215-273-8755 (collect)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 119 g Tube Carton LISTERINE ® ESSENTIAL CARE ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL FRESHENS BREATH THE LISTERINE ® WAY POWERFULL MINT GEL Kills the Germs that Cause Bad Breath Helps Prevent Cavities Removes Stains NET WT. 4.2 OZ. (119 g) Listerine_1"
      ],
      "set_id": "90b5c3d8-baa4-44ab-8f73-e177007f0219",
      "id": "40c937f3-618c-1c3d-e063-6294a90a35cf",
      "effective_time": "20251010",
      "version": "5",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Listerine Essential Care"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0701"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "40c937f3-618c-1c3d-e063-6294a90a35cf"
        ],
        "spl_set_id": [
          "90b5c3d8-baa4-44ab-8f73-e177007f0219"
        ],
        "package_ndc": [
          "69968-0701-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0312547434553"
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      }
    }
  ]
}