{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Cold Sore Fever Blister Treatment Docosanol DOCOSANOL DOCOSANOL BENZYL ALCOHOL LIGHT MINERAL OIL PROPYLENE GLYCOL WATER SUCROSE DISTEARATE (HLB 5) SUCROSE STEARATE"
      ],
      "active_ingredient": [
        "Active ingredient Docosanol 10%"
      ],
      "purpose": [
        "Purpose Cold sore/fever blister treatment"
      ],
      "indications_and_usage": [
        "Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching"
      ],
      "warnings": [
        "Warnings Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only"
      ],
      "do_not_use": [
        "Do not use if you are allergic to any ingredient in this product"
      ],
      "when_using": [
        "When using this product apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread the infection."
      ],
      "stop_use": [
        "Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle). early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor"
      ],
      "spl_unclassified_section": [
        "Other information store at 20°-25°C (68°-77°F) do not freeze"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate"
      ],
      "questions": [
        "Questions or comments? Call 1-800-632-6900"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel COMPARE TO THE ACTIVE INGREDIENT IN ABREVA® COLD SORE TREATMENT PUMP† Docosanol Cream, 10% Cold Sore/Fever Blister Treatment Only FDA-approved medicine to shorten healing time* Portable convenient pump NET WT 2 g (0.07 oz) *Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms. *Abreva® is a registered trademark of Haleon UK IP Limited RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202",
        "Package Label KROGER HEALTH Cold Sore Fever Blister Treatment Docosanol 10%"
      ],
      "set_id": "07fc9c8d-dee7-4a69-bb7a-0f3001a4ebb3",
      "id": "b02d8fe2-0f76-44d9-ac83-037aaf714416",
      "effective_time": "20241017",
      "version": "3",
      "openfda": {
        "application_number": [
          "ANDA212385"
        ],
        "brand_name": [
          "Cold Sore Fever Blister Treatment"
        ],
        "generic_name": [
          "DOCOSANOL"
        ],
        "manufacturer_name": [
          "The Kroger Co."
        ],
        "product_ndc": [
          "30142-869"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DOCOSANOL"
        ],
        "rxcui": [
          "797534"
        ],
        "spl_id": [
          "b02d8fe2-0f76-44d9-ac83-037aaf714416"
        ],
        "spl_set_id": [
          "07fc9c8d-dee7-4a69-bb7a-0f3001a4ebb3"
        ],
        "package_ndc": [
          "30142-869-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041260015571"
        ],
        "unii": [
          "9G1OE216XY"
        ]
      }
    }
  ]
}