{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA021394"
        ],
        "brand_name": [
          "ADVIL PM"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE CITRATE AND IBUPROFEN"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0573-0164"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE CITRATE",
          "IBUPROFEN"
        ],
        "rxcui": [
          "895664"
        ],
        "spl_id": [
          "15971707-84cd-4742-e063-6394a90af906"
        ],
        "spl_set_id": [
          "658fc201-47c9-6a6d-8af9-6208298d43b4"
        ],
        "package_ndc": [
          "0573-0164-33",
          "0573-0164-04",
          "0573-0164-20",
          "0573-0164-30",
          "0573-0164-40",
          "0573-0164-43",
          "0573-0164-45",
          "0573-0164-32",
          "0573-0164-41",
          "0573-0164-91",
          "0573-0164-05",
          "0573-0164-55",
          "0573-0164-21",
          "0573-0164-44",
          "0573-0164-14",
          "0573-0164-12",
          "0573-0164-49",
          "0573-0164-46",
          "0573-0164-65",
          "0573-0164-08",
          "0573-0164-09"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "4OD433S209",
          "WK2XYI10QM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67617",
      "recalling_firm": "Pfizer Us Pharmaceutical Group",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1166-2014",
      "product_description": "Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43",
      "product_quantity": "70,704 bottles",
      "reason_for_recall": "Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.",
      "recall_initiation_date": "20140226",
      "center_classification_date": "20140318",
      "termination_date": "20150710",
      "report_date": "20140326",
      "code_info": "G85041",
      "more_code_info": ""
    }
  ]
}