{
  "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": "20071227",
          "application_docs": [
            {
              "id": "9145",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078336ltr.pdf",
              "date": "20080109",
              "type": "Letter"
            },
            {
              "id": "18480",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078336lbl.pdf",
              "date": "20080108",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20100527",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA078336",
      "sponsor_name": "PERRIGO R AND D",
      "openfda": {
        "application_number": [
          "ANDA078336"
        ],
        "brand_name": [
          "BETR REMEDIES ALL DAY ALLERGY RELIEF",
          "DG HEALTH ALL DAY ALLERGY",
          "BERKLEY AND JENSEN ALL DAY ALLERGY",
          "ALLERGY RELIEF",
          "ALL DAY ALLERGY",
          "EQUATE ALLERGY RELIEF",
          "WELBY ALLERGY RELIEF",
          "24 HOUR ALLERGY",
          "REXALL ALL DAY ALLERGY RELIEF",
          "EXCHANGE SELECT ALL DAY ALLERGY",
          "KIRKLAND SIGNATURE ALLER TEC ALLERGY",
          "CETIRIZINE",
          "LEADER ALL DAY ALLERGY",
          "SIGNATURE CARE ALLERGY RELIEF",
          "CETIRIZINE HYDROCHLORIDE",
          "CAREONE ALLERGY RELIEF",
          "BASIC CARE ALL DAY ALLERGY",
          "GOOD SENSE ALL DAY ALLERGY",
          "ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES",
          "MEMBERS MARK ALLERGY RELIEF",
          "UP AND UP ALLERGY RELIEF",
          "GOODNOW ALLERGY RELIEF",
          "TOPCARE ALL DAY ALLERGY",
          "EQUALINE ALL DAY ALLERGY",
          "GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY"
        ],
        "generic_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Live Betr LLC",
          "Dolgencorp Inc",
          "BJWC",
          "Safeway",
          "HyVee Inc",
          "Wal-Mart Stores Inc",
          "Aldi Inc",
          "Meijer Distribution Inc",
          "Dolgencorp, LLC",
          "Army & Air Force Exchange Service",
          "Walgreen Company",
          "Costco Wholesale Company",
          "Major Pharmaceuticals",
          "Cardinal Health 110, LLC. dba Leader",
          "H E B",
          "Padagis Israel Pharmaceuticals Ltd",
          "American Sales Company",
          "Amazon.com Services LLC",
          "L. Perrigo Company",
          "CVS Pharmacy",
          "Sam's West Inc",
          "Target Corporation",
          "Gobrands, Inc",
          "Rite Aid Corporation",
          "Topco Associates LLC",
          "United Natural Foods, Inc. dba UNFI",
          "Amerisource Bergen"
        ],
        "product_ndc": [
          "80267-409",
          "55910-458",
          "68391-400",
          "21130-425",
          "42507-458",
          "49035-458",
          "64024-499",
          "41250-458",
          "55910-699",
          "55301-076",
          "0363-4101",
          "63981-458",
          "0904-6717",
          "70000-0380",
          "21130-090",
          "37808-583",
          "45802-919",
          "41520-781",
          "72288-411",
          "0113-9458",
          "59779-458",
          "68196-413",
          "11673-502",
          "82501-0422",
          "11822-1002",
          "36800-458",
          "41163-458",
          "24385-998"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CETIRIZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1014678",
          "1991946"
        ],
        "spl_id": [
          "4a017852-db01-4085-8947-d92a19ec4e5c",
          "54199e31-e4b5-407e-97eb-dc35ed4de5a1",
          "09c3300a-a96f-4967-aa1d-85b6e9fd5798",
          "8b6eebd5-99d8-4acf-aec4-2b1c8d32ed4b",
          "a9ba17ab-f223-4850-a8c4-96ae247ed081",
          "778691fe-e505-40b6-91e7-b81ae4fa45c9",
          "2324487c-1a2c-42b1-a018-22f7ee9d5bcd",
          "18b74fff-8596-4050-93ee-4f15e6811de4",
          "eba98b0b-bc85-4d05-8875-86b85bd462b4",
          "e61a6e00-ceae-4a3b-bbf8-ead4edc14d59",
          "5cb9e952-68d7-4a0b-a6c0-d07c4ee63b16",
          "11b36474-0f5b-4454-8e5e-023c36ddad54",
          "cdf7d985-c5aa-4002-a152-58fe4d6ba6e2",
          "f547a78c-52a9-40c8-b48c-7e76681b9c5d",
          "4a207903-34f2-4db3-a813-e02bd7f93053",
          "e2ba6632-3350-4d5f-a03e-5e68dce98576",
          "431bdf74-dfe3-4e4f-91e9-2b638ada6d47",
          "11e72e08-b407-4a84-a79e-1f14b987b1ec",
          "36de155a-75d8-471a-be42-56bf64a7b39a",
          "c93a5e52-e438-4421-bdca-1fcfdcdb9b98",
          "131dd209-e1fe-4dd4-9523-8c0da50b78f4",
          "f8834e23-1240-4098-95f2-c8e31d6c2c64",
          "8f32f92c-9043-439d-a318-8f4ae6b1ad39",
          "5d8e3ec6-14de-463d-bea1-d40f50266304",
          "6c4b2dd2-0897-4bcb-a570-6bc6f5332828",
          "dc4e4803-536c-4a2b-9faa-e307a66eb91a",
          "6e7bab3d-af1a-4b74-921d-99aca2aa0fd3",
          "49064fc4-3c0c-4d8f-9576-f57ad03f9cfe"
        ],
        "spl_set_id": [
          "4a017852-db01-4085-8947-d92a19ec4e5c",
          "b9ac489a-80ed-4077-b68e-d03df1b892a6",
          "b38c0068-5b06-4976-b68d-617bcc14f051",
          "c5e74b2c-7871-4f28-a77d-0d674b9b8c5e",
          "8889af37-8345-4358-994d-7d8b847f4874",
          "b33eb97f-5ac3-4eb7-b23a-cf550ce46287",
          "cf6b3017-c8b6-4862-aa33-19ed02a43c28",
          "2b03c026-3e8a-4283-981f-965bc084c03d",
          "4d79fb74-1895-4efe-8016-c0dd5ed10f7a",
          "e7220494-3640-4b33-b577-ed3ca7c483e8",
          "678dcc09-55da-4d9d-a39a-c450c61c387b",
          "d4a688aa-02d4-4af6-9a91-ed31679cfaf8",
          "a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3",
          "ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf",
          "24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0",
          "8649fc1e-ad56-4660-bbbb-8f1ed795697b",
          "91fe3ab8-c155-4482-9f06-f029d3563aad",
          "533abfc1-226e-4a68-bfcc-ec046a4d5751",
          "af8ff570-8f72-4343-b7e1-e977221f5b01",
          "2a7a27ab-1b4c-40d1-98bf-e4297aa25682",
          "98f3f2c6-da18-4055-81f1-962261360f9b",
          "379756fd-f92d-4773-94fd-2682fcbdfba2",
          "ce93ca5b-2a65-4873-9686-926c44076c6c",
          "86ade508-8841-47d8-addb-418ecd6dc8de",
          "bcbb9f5a-10b6-4a5e-a237-d29693d78103",
          "f2919aad-9ed4-40b8-b233-4aec06df33ea",
          "491fae66-83b6-4beb-945b-39b9e4e021c5",
          "c568e388-60ab-47be-b362-7832b83d06ad"
        ],
        "package_ndc": [
          "80267-409-95",
          "55910-458-00",
          "55910-458-39",
          "55910-458-95",
          "55910-458-58",
          "55910-458-66",
          "68391-400-00",
          "68391-400-01",
          "21130-425-95",
          "42507-458-30",
          "42507-458-39",
          "42507-458-66",
          "42507-458-60",
          "42507-458-72",
          "42507-458-45",
          "42507-458-95",
          "42507-458-90",
          "42507-458-75",
          "42507-458-06",
          "42507-458-00",
          "42507-458-87",
          "49035-458-95",
          "49035-458-75",
          "49035-458-66",
          "49035-458-87",
          "49035-458-48",
          "49035-458-51",
          "64024-499-39",
          "41250-458-66",
          "41250-458-39",
          "41250-458-95",
          "41250-458-72",
          "41250-458-75",
          "41250-458-87",
          "41250-458-58",
          "41250-458-13",
          "55910-699-66",
          "55301-076-95",
          "55301-076-39",
          "0363-4101-75",
          "0363-4101-39",
          "0363-4101-88",
          "0363-4101-13",
          "0363-4101-47",
          "0363-4101-58",
          "0363-4101-66",
          "0363-4101-72",
          "0363-4101-95",
          "63981-458-88",
          "63981-458-00",
          "0904-6717-41",
          "0904-6717-43",
          "0904-6717-40",
          "0904-6717-72",
          "0904-6717-60",
          "0904-6717-86",
          "0904-6717-46",
          "0904-6717-61",
          "70000-0380-3",
          "70000-0380-2",
          "70000-0380-4",
          "70000-0380-1",
          "21130-090-66",
          "21130-090-76",
          "21130-090-39",
          "21130-090-95",
          "21130-090-72",
          "21130-090-75",
          "21130-090-48",
          "37808-583-06",
          "37808-583-58",
          "37808-583-39",
          "37808-583-66",
          "37808-583-76",
          "37808-583-00",
          "37808-583-87",
          "45802-919-87",
          "45802-919-39",
          "41520-781-66",
          "41520-781-06",
          "41520-781-39",
          "41520-781-75",
          "41520-781-95",
          "41520-781-76",
          "41520-781-58",
          "72288-411-87",
          "72288-411-75",
          "72288-411-39",
          "72288-411-88",
          "0113-9458-13",
          "0113-9458-66",
          "0113-9458-95",
          "0113-9458-39",
          "0113-9458-88",
          "0113-9458-58",
          "0113-9458-04",
          "0113-9458-75",
          "59779-458-13",
          "59779-458-39",
          "59779-458-95",
          "59779-458-75",
          "59779-458-76",
          "59779-458-88",
          "59779-458-66",
          "59779-458-72",
          "59779-458-70",
          "59779-458-58",
          "59779-458-06",
          "59779-458-00",
          "59779-458-05",
          "59779-458-01",
          "68196-413-82",
          "68196-413-79",
          "11673-502-58",
          "11673-502-75",
          "11673-502-48",
          "11673-502-06",
          "11673-502-39",
          "11673-502-74",
          "11673-502-87",
          "11673-502-76",
          "11673-502-72",
          "11673-502-00",
          "82501-0422-0",
          "82501-0422-1",
          "11822-1002-4",
          "11822-1002-2",
          "11822-1002-1",
          "11822-1002-3",
          "11822-1002-8",
          "11822-1002-7",
          "36800-458-13",
          "36800-458-66",
          "36800-458-39",
          "36800-458-95",
          "36800-458-72",
          "36800-458-75",
          "36800-458-47",
          "36800-458-87",
          "36800-458-06",
          "36800-458-58",
          "41163-458-39",
          "41163-458-66",
          "41163-458-72",
          "41163-458-76",
          "41163-458-95",
          "41163-458-58",
          "24385-998-74",
          "24385-998-65",
          "24385-998-75",
          "24385-998-58"
        ],
        "unii": [
          "64O047KTOA"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "CETIRIZINE HYDROCHLORIDE HIVES",
          "active_ingredients": [
            {
              "name": "CETIRIZINE HYDROCHLORIDE",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CETIRIZINE HYDROCHLORIDE ALLERGY",
          "active_ingredients": [
            {
              "name": "CETIRIZINE HYDROCHLORIDE",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "CETIRIZINE HYDROCHLORIDE HIVES",
          "active_ingredients": [
            {
              "name": "CETIRIZINE HYDROCHLORIDE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CETIRIZINE HYDROCHLORIDE ALLERGY",
          "active_ingredients": [
            {
              "name": "CETIRIZINE HYDROCHLORIDE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}