{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cedar Knolls",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "DERMOPLAST FIRST AID"
        ],
        "generic_name": [
          "BENZETHONIUM CHLORIDE AND BENZOCAINE"
        ],
        "manufacturer_name": [
          "Advantice Health, LLC"
        ],
        "product_ndc": [
          "16864-670"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZETHONIUM CHLORIDE",
          "BENZOCAINE"
        ],
        "rxcui": [
          "1049108",
          "1101914"
        ],
        "spl_id": [
          "4849d774-4d2d-2d24-e063-6294a90ab234"
        ],
        "spl_set_id": [
          "ec93011d-7069-4021-8dd2-3d51eb6026e1"
        ],
        "package_ndc": [
          "16864-670-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "PH41D05744",
          "U3RSY48JW5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91581",
      "recalling_firm": "Advantice Health, Llc",
      "address_1": "7 E Frederick Pl Ste 100",
      "address_2": "N/A",
      "postal_code": "07927-1815",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed via the internet, distributors and retailers nationwide.",
      "recall_number": "D-0329-2023",
      "product_description": "Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01",
      "product_quantity": "16,152 cans/673 cases",
      "reason_for_recall": "Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.",
      "recall_initiation_date": "20230202",
      "center_classification_date": "20230217",
      "termination_date": "20231031",
      "report_date": "20230301",
      "code_info": "Lot # 22336A"
    }
  ]
}