{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Antiseptic Mouth Rinse Eucalyptol ALCOHOL WATER SORBITOL POLOXAMER 407 BENZOIC ACID SACCHARIN SODIUM SODIUM CITRATE D&C YELLOW NO. 10 FD&C GREEN NO. 3 EUCALYPTOL EUCALYPTOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID THYMOL THYMOL"
      ],
      "active_ingredient": [
        "Active ingredients Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064% Purpose Antigingivitis, Antiplaque"
      ],
      "purpose": [
        "Purpose Antigingivitis, Antiplaque"
      ],
      "indications_and_usage": [
        "Use helps control plaque that leads to gingivitis"
      ],
      "warnings": [
        "Warnings for this product 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 and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks. 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."
      ],
      "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 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 (59⁰ - 77⁰F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, D&C yellow no.10, FD&C green no.3"
      ],
      "adverse_reactions": [
        "Adverse Reaction *This product is not manufactured or distributed by Kenvue, Inc., distributor of FreshBurst ® Listerine ® Antiseptic Mouthwash. OUR PROMISE: Gluten Free** **While this product has no added gluten, there is no guarantee that this product's ingredients have not been exposed to gluten. DISTRIBUTED BY: RITE AID 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com SATISFACTION GUARANTEE If you're not satisfied, we'll happily refund your money. DSP-TN-21091 DSP-MO-20087"
      ],
      "package_label_principal_display_panel": [
        "principal display panel Sealed with printed neckband for your protection *Compare to FreshBurst ® Listerine ® Antiseptic Mouthwash FREE FROM - GLUTEN FREE** ANTISEPTIC MOUTHWASH ANTIGINGIVITIS/ANTIPLAQUE RINSE FRESH MINT helps reduce plaque & gingivitis fights bad breath child-resistant cap ADA Accepted American Dental Association Helps prevent and reduce plaque Helps prevent and reduce gingivitis 1L (1.05 QT) 33.8 FL OZ image description"
      ],
      "set_id": "0f41f4fa-bfcc-4ae7-b173-52a0a9a6366c",
      "id": "499f1591-7356-8cfd-e063-6294a90ada22",
      "effective_time": "20260130",
      "version": "15",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Antiseptic Mouth Rinse"
        ],
        "generic_name": [
          "EUCALYPTOL"
        ],
        "manufacturer_name": [
          "Rite Aid Corporation"
        ],
        "product_ndc": [
          "11822-0072"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EUCALYPTOL",
          "MENTHOL",
          "METHYL SALICYLATE",
          "THYMOL"
        ],
        "rxcui": [
          "1043619"
        ],
        "spl_id": [
          "499f1591-7356-8cfd-e063-6294a90ada22"
        ],
        "spl_set_id": [
          "0f41f4fa-bfcc-4ae7-b173-52a0a9a6366c"
        ],
        "package_ndc": [
          "11822-0072-1",
          "11822-0072-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RV6J6604TK",
          "L7T10EIP3A",
          "LAV5U5022Y",
          "3J50XA376E"
        ]
      }
    }
  ]
}