{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20251217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20251001",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20240327",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230713",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA216592",
      "sponsor_name": "GRANULES",
      "openfda": {
        "application_number": [
          "ANDA216592"
        ],
        "brand_name": [
          "PERIOD PILLS BY BIIKAY",
          "ACETAMINOPHEN AND IBUPROFEN",
          "ACETAMINOPHEN AND IBUPROFEN (NSAID)",
          "ACETAMINOPHEN AND IBUPROFEN BACK PAIN",
          "DUAL ACTION PAIN RELIEF",
          "ACETAMINOPHEN",
          "AACETAMINOPHEN AND IBUPROFEN"
        ],
        "generic_name": [
          "ACETAMINOPHEN, IBUPROFEN",
          "ACETAMINOPHEN AND IBUPROFEN",
          "ACETAMINOPHEN AND IBUPROFEN (NSAID)",
          "DUAL ACTION PAIN RELIEF",
          "ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "Kai Squared",
          "WAL-MART STORES INC.",
          "RITE AID",
          "Granules Pharmaceuticals Inc.",
          "CVS",
          "Wal-Mart Stores Inc.",
          "RUGBY LABORATORIES",
          "Family Dollar",
          "WALGREENS",
          "RETAIL BUSINESS SERVICES,LLC",
          "Allegiant Health",
          "RAONBIO CORP",
          "LEADER/ Cardinal Health 110, Inc.",
          "GRANULES USA, INC."
        ],
        "product_ndc": [
          "85576-101",
          "79903-244",
          "11822-1131",
          "70010-213",
          "51316-131",
          "79903-931",
          "0536-1376",
          "55319-139",
          "70010-131",
          "0363-9131",
          "72476-131",
          "69168-462",
          "70038-131",
          "70000-0622",
          "69848-588",
          "51316-132"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "IBUPROFEN"
        ],
        "rxcui": [
          "2387532"
        ],
        "spl_id": [
          "4d9d6b04-6318-1933-e063-6394a90adde7",
          "464fe21f-7b71-6aef-e063-6294a90a03f8",
          "4654faae-9084-7bb5-e063-6394a90acca2",
          "32562a4b-8df6-55fb-e063-6394a90ae483",
          "46545016-29d2-7e81-e063-6294a90a941f",
          "00b3b488-8bb2-0fee-e063-6294a90a4d26",
          "4653226b-ab67-b59c-e063-6294a90aa02a",
          "4654caab-ace3-4fdb-e063-6394a90a0b1b",
          "36a6254f-9451-951a-e063-6394a90a61d0",
          "4653ceee-cd77-c747-e063-6294a90a95b1",
          "4652acf2-7ec6-eff9-e063-6294a90ac499",
          "cd52df09-a439-4a7e-b593-d2255f4a2275",
          "4652d772-fe08-2ce4-e063-6294a90a1ddd",
          "4652fd1e-ed26-2a97-e063-6394a90a7e1a",
          "2a306431-7813-346e-e063-6294a90aca46",
          "46547b4f-b369-f246-e063-6394a90a3200"
        ],
        "spl_set_id": [
          "40d2ae73-82cf-3fa1-e063-6394a90a9ea2",
          "0aaddde9-4317-a828-e063-6294a90a26d5",
          "e64c0ec1-2889-96d1-e053-2995a90a8568",
          "32562aa1-f44b-649e-e063-6394a90a47c8",
          "e45830a0-c884-e556-e053-2995a90ab565",
          "e7b36e3c-0e8a-1aeb-e053-2995a90a51a4",
          "ed340993-04e6-b084-e053-2a95a90abf60",
          "fe095058-5ecb-75b3-e053-6394a90afb6c",
          "0f8b9524-8fe3-47cf-bacd-93047442d90d",
          "e457af7c-0fa7-a47e-e053-2a95a90abf9c",
          "e7b7009a-89a4-720d-e053-2a95a90abff7",
          "fb4fc347-0f90-429f-9ca8-903e736f5496",
          "f6f5251d-db89-4b69-e053-6394a90a1028",
          "f1d69088-4d52-cbb5-e053-2995a90a3ec8",
          "1dd90684-6505-8e07-e063-6394a90afdf4",
          "f0d3f0ab-07ee-f068-e053-2995a90a481a"
        ],
        "package_ndc": [
          "85576-101-36",
          "79903-244-44",
          "11822-1131-6",
          "11822-1131-4",
          "70010-213-26",
          "70010-213-31",
          "51316-131-36",
          "51316-131-72",
          "51316-131-44",
          "79903-931-44",
          "0536-1376-36",
          "55319-139-36",
          "70010-131-26",
          "70010-131-31",
          "0363-9131-16",
          "0363-9131-44",
          "72476-131-81",
          "72476-131-72",
          "69168-462-35",
          "69168-462-02",
          "69168-462-17",
          "70038-131-81",
          "70038-131-36",
          "70038-131-72",
          "70000-0622-1",
          "70000-0622-2",
          "69848-588-72",
          "51316-132-81",
          "51316-132-72"
        ],
        "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": [
          "362O9ITL9D",
          "WK2XYI10QM"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ACETAMINOPHEN AND IBUPROFEN",
          "active_ingredients": [
            {
              "name": "ACETAMINOPHEN",
              "strength": "250MG"
            },
            {
              "name": "IBUPROFEN",
              "strength": "125MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}