{
  "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": [
        "ABREVA Rapid Pain Relief glycerin, lidocaine HYDROXYETHYL CELLULOSE, UNSPECIFIED MENTHOL, UNSPECIFIED FORM METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN TRISODIUM CITRATE DIHYDRATE WATER GLYCERIN GLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS"
      ],
      "active_ingredient": [
        "Active ingredients Glycerin 20% Lidocaine HCl 4%"
      ],
      "purpose": [
        "Purposes Lip Protectant External Analgesic"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with cold sores and fever blisters Relieves dryness and softens cold sores and fever blisters Softens crust (scabs) associated with cold sores and fever blisters"
      ],
      "warnings": [
        "Warnings For external use only Do not use in large quantities, particularly over raw surfaces, or blistered areas When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in large quantities, particularly over raw surfaces, or blistered areas"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions push and turn cap to open, close tightly after use wash hands before and after applying adults and children 12 years of age and older : apply to affected area not more than 3 to 4 times daily children under 12 years : consult a doctor"
      ],
      "storage_and_handling": [
        "Other information store at 20-25 o C (68 o -77 o F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol, propylparaben, trisodium citrate dihydrate, water"
      ],
      "questions": [
        "Questions or comments? 1-877-709-3539"
      ],
      "spl_unclassified_section": [
        "Additional Information Retain outer carton for full product uses, directions and warnings. Do not use if carton is broken or damaged. CARTON Recycle"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel abreva RAPID PAIN RELIEF Cold Sore MAX STRENGTH LIDOCAINE For rapid numbing effect Lidocaine HCl 4% / Glycerin 20% External Analgesic / Lip Protectant NET WT 3 g (0.10 oz) PA 202119 – Front Panel PA 202119 Abreva Rapid Pain Relief 3g"
      ],
      "set_id": "65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d",
      "id": "1b52dd69-d74d-3137-e063-6394a90ab541",
      "effective_time": "20240620",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "ABREVA Rapid Pain Relief"
        ],
        "generic_name": [
          "GLYCERIN, LIDOCAINE"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "GLYCERIN",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "2637870",
          "2637875"
        ],
        "spl_id": [
          "1b52dd69-d74d-3137-e063-6394a90ab541"
        ],
        "spl_set_id": [
          "65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d"
        ],
        "package_ndc": [
          "0135-0400-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "PDC6A3C0OX",
          "V13007Z41A"
        ]
      }
    }
  ]
}