{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Antispetic Eucalyptol, menthol, methyl salicylate, thymol WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM BENZOATE FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL"
      ],
      "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 Cool Mint ® Listerine ® Antiseptic Mouthwash."
      ],
      "active_ingredient": [
        "Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%"
      ],
      "purpose": [
        "Purpose Antigingivitis, Antiplaque"
      ],
      "indications_and_usage": [
        "Use helps control plaque that leads to gingivitis"
      ],
      "warnings": [
        "Warnings for this product"
      ],
      "do_not_use": [
        "Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease."
      ],
      "stop_use": [
        "Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks"
      ],
      "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 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing"
      ],
      "storage_and_handling": [
        "Other information cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)."
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, green 3"
      ],
      "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. New Square Kashrus DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "Principle Panel Display COMPARE TO LISTERINE ® * mint'evo EVOLUTIONIZING ORAL FRESHNESS ANTISEPTIC MOUTHWASH ANTIGINGIVITIS / ANTIPLAQUE KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND GINGIVITIS GUM DISEASE BLUE MINT ADA Accepted American Dental Association ® Helps prevent and reduce plaque Helps prevent and reduce gingivitis 1 L (1.05 QT) 33.8 FL OZ image description image description"
      ],
      "set_id": "1bbae739-5e54-64cb-e063-6294a90a3745",
      "id": "5241bf71-869f-3bdc-e063-6394a90a6da9",
      "effective_time": "20260520",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Antispetic"
        ],
        "generic_name": [
          "EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL"
        ],
        "manufacturer_name": [
          "Rockland Cosmetics, Inc."
        ],
        "product_ndc": [
          "69892-664"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "5241bf71-869f-3bdc-e063-6394a90a6da9"
        ],
        "spl_set_id": [
          "1bbae739-5e54-64cb-e063-6294a90a3745"
        ],
        "package_ndc": [
          "69892-664-19",
          "69892-664-77",
          "69892-664-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}