{
  "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": "2026-08-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090710"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20160623",
          "review_priority": "UNKNOWN",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20160623",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20160721",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160623",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA090711",
      "sponsor_name": "PPI-DAC",
      "openfda": {
        "application_number": [
          "ANDA090711"
        ],
        "brand_name": [
          "KIRKLAND SIGNATURE NICOTINE",
          "NICOTINE",
          "EQUATE NICOTINE",
          "BASIC CARE NICOTINE",
          "TOPCARE NICOTINE POLACRILEX",
          "GOOD SENSE NICOTINE",
          "QUITINE NICOTINE",
          "TOPCARE NICOTINE",
          "UP AND UP CHERRY NICOTINE"
        ],
        "generic_name": [
          "NICOTINE",
          "NICOTINE POLACRILEX"
        ],
        "manufacturer_name": [
          "Costco Wholesale Company",
          "Walgreen Company",
          "Wal-Mart Stores Inc",
          "Publix Super Markets Inc",
          "H E B",
          "Amazon.com Services LLC",
          "Topco Associates LLC",
          "L. Perrigo Company",
          "Rite Aid Corporation",
          "QUITINE LLC",
          "Kroger Company",
          "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
          "CVS Pharmacy",
          "Meijer Distribution Inc",
          "Target Corporation"
        ],
        "product_ndc": [
          "63981-124",
          "0363-0124",
          "49035-190",
          "56062-499",
          "37808-383",
          "72288-124",
          "36800-375",
          "0113-1125",
          "11822-0124",
          "0113-1190",
          "84720-124",
          "0363-4190",
          "36800-539",
          "30142-190",
          "49035-124",
          "30142-124",
          "56062-509",
          "51316-190",
          "72288-190",
          "59779-397",
          "72288-771",
          "41250-700",
          "82442-190",
          "82442-124",
          "37808-533",
          "41250-190",
          "11822-0009",
          "63981-190",
          "84720-190"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "359817",
          "359818"
        ],
        "spl_id": [
          "f67f9328-6575-4c79-ab5c-ee1e9b46eb96",
          "0ba190cf-8759-426e-aad1-9a9429c80842",
          "e56b903c-4989-447b-9613-ce4e46679641",
          "4a750326-89ae-43db-a017-8d85c8223be6",
          "fbecca27-2bc4-4673-ba65-b6fd6a446218",
          "e3a609b4-be67-4197-84c1-80a0ed9971fb",
          "6a0be9fe-8359-4fce-a4bf-cfc3f6832a23",
          "942977e1-d463-44fe-bbb7-864fd54dfc4e",
          "fdc04364-11ec-4f68-b844-5d9df23aec2b",
          "69c7b6f8-7200-4b9e-ac85-2e2c5c5eeda7",
          "bb6f505e-7311-4b3a-ada9-c3f57ee059e8",
          "1cfddf2c-38d8-4d74-8d96-6f42efe7650d",
          "d8a7c0b8-ccf2-44e8-8041-f71ea7359ba2",
          "a89069c9-e4ef-4da4-a49f-36961d03a97b",
          "853e0097-c2c8-4869-8a20-980b1b7f449d",
          "788f735f-baf3-4368-a291-3e20d4ae4f0b",
          "7551c8cf-6a87-4ecd-b10a-9c0738d7deea",
          "6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2",
          "10e859cf-3194-4624-9f47-606fae0ca58c",
          "f8fcf4fe-2c57-4c18-a799-c5ba8bc0c998",
          "79472c2a-544d-4cb0-a357-5903768d45fa",
          "352fb71d-be46-4d6f-a70d-c42db3e2276a",
          "116a02ad-c5b9-44d2-8a76-2110e7da6fac",
          "315edfa2-b662-402e-9ed5-72f35616bd74",
          "56f142f0-fb0c-4e01-91a0-50ce317d8962",
          "9e89ae28-ac76-4d10-8ccd-455f14f9f64b",
          "9729f04c-366d-479f-9bce-4c5ee507b8f1",
          "b864361c-f31a-4bdf-b033-828f7f204f1e",
          "08f257a6-7361-4d10-b3d2-59dec1a69281"
        ],
        "spl_set_id": [
          "33098a72-9146-4547-9d0b-ff28c8c80030",
          "4a81d378-009d-43a9-a895-e371ffa700e9",
          "0100787d-59f0-4f7f-ac13-92d1162cdc1b",
          "8c296647-00a1-43d0-acd1-7c1e92f36883",
          "98633912-74d8-49db-a03e-4a3f882297ac",
          "6f73126a-32e5-48b9-8013-6afb0ebe8fd8",
          "d0403746-f866-42da-ad66-2a686c8bce01",
          "dd334b2c-bbae-48e7-8f3d-2706d325f600",
          "6020abb5-2a4f-4602-8014-e2b4e462c05f",
          "69c7b6f8-7200-4b9e-ac85-2e2c5c5eeda7",
          "90232b4e-cbf4-4d03-973a-41f4ebb4e5de",
          "74f306d4-2a71-48c9-ab98-378260507a9d",
          "99da90fa-00ff-4c62-91a2-1e434dadaf41",
          "69a61101-df32-444e-a49a-eccfeebfb20e",
          "d0e94dfb-017a-4faf-8423-3417d517f39c",
          "e4a7cf2a-5fd9-4390-8517-e532900ff81c",
          "a9402b4b-f8e6-4e96-ad45-5875dfd0c889",
          "114418c4-6f39-46ce-912c-ac3687b7b75e",
          "47561b44-572e-4ca0-b91c-db0706131363",
          "5f7b8d7f-b99a-4f1d-82ad-6a27b6c381b2",
          "ec341a77-5b62-4980-8d31-27c12ae92561",
          "3566423d-3ddb-4913-9da5-fb43680f0efc",
          "85d82812-9f90-401f-8a2c-729cbfdf4c78",
          "4e0d57ea-749f-48ff-b6f1-3cbd0963d11e",
          "691f3f8d-7242-4855-b80b-4d5af0490b37",
          "18ee7d8b-7b18-404e-8e62-c10355bb0a26",
          "f1eb8d9f-1c9a-4c8a-833b-ced0ec01ed5c",
          "0888a974-a8ba-4cb3-996f-c8abfcb90a6f",
          "5d23992f-a010-4604-b64c-94ab6b134e6d"
        ],
        "package_ndc": [
          "63981-124-37",
          "0363-0124-09",
          "0363-0124-10",
          "0363-0124-03",
          "0363-0124-06",
          "0363-0124-05",
          "49035-190-10",
          "49035-190-09",
          "56062-499-03",
          "37808-383-10",
          "72288-124-05",
          "72288-124-11",
          "36800-375-03",
          "36800-375-05",
          "0113-1125-09",
          "0113-1125-10",
          "0113-1125-24",
          "0113-1125-05",
          "11822-0124-1",
          "0113-1190-10",
          "84720-124-00",
          "84720-124-11",
          "0363-4190-03",
          "0363-4190-05",
          "0363-4190-06",
          "0363-4190-09",
          "0363-4190-10",
          "36800-539-03",
          "36800-539-05",
          "30142-190-03",
          "30142-190-05",
          "30142-190-06",
          "49035-124-10",
          "49035-124-09",
          "30142-124-05",
          "30142-124-06",
          "56062-509-03",
          "51316-190-09",
          "51316-190-10",
          "72288-190-03",
          "72288-190-05",
          "72288-190-11",
          "59779-397-06",
          "59779-397-05",
          "59779-397-11",
          "59779-397-03",
          "59779-397-09",
          "59779-397-10",
          "72288-771-24",
          "72288-771-05",
          "41250-700-03",
          "41250-700-05",
          "41250-700-09",
          "41250-700-10",
          "82442-190-05",
          "82442-190-03",
          "82442-124-05",
          "82442-124-03",
          "37808-533-10",
          "41250-190-03",
          "41250-190-05",
          "41250-190-09",
          "41250-190-10",
          "11822-0009-1",
          "63981-190-37",
          "84720-190-00",
          "84720-190-11"
        ],
        "nui": [
          "N0000175706",
          "M0014836"
        ],
        "pharm_class_epc": [
          "Cholinergic Nicotinic Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotine [CS]"
        ],
        "unii": [
          "6M3C89ZY6R"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "NICOTINE POLACRILEX",
          "active_ingredients": [
            {
              "name": "NICOTINE POLACRILEX",
              "strength": "EQ 2MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TROCHE/LOZENGE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "NICOTINE POLACRILEX",
          "active_ingredients": [
            {
              "name": "NICOTINE POLACRILEX",
              "strength": "EQ 4MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TROCHE/LOZENGE",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}