{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "82568-0016",
      "generic_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML",
      "labeler_name": "AARNA USA INC.",
      "brand_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML",
      "active_ingredients": [
        {
          "name": "DIPHENHYDRAMINE",
          "strength": "12.5 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "82568-0016-4",
          "description": "118 mL in 1 BOTTLE (82568-0016-4)",
          "marketing_start_date": "20250414",
          "sample": false
        },
        {
          "package_ndc": "82568-0016-6",
          "description": "473 mL in 1 BOTTLE (82568-0016-6)",
          "marketing_start_date": "20250414",
          "sample": false
        },
        {
          "package_ndc": "82568-0016-8",
          "description": "236 mL in 1 BOTTLE (82568-0016-8)",
          "marketing_start_date": "20250414",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "AARNA USA INC."
        ],
        "rxcui": [
          "1049906"
        ],
        "spl_set_id": [
          "32c26835-f54e-d7e5-e063-6294a90ae1c0"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000190",
          "N0000175587"
        ],
        "pharm_class_moa": [
          "Histamine H1 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-1 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "8GTS82S83M"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "SOLUTION",
      "spl_id": "3404aa22-166f-5501-e063-6394a90a1e7a",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20250414",
      "product_id": "82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a",
      "application_number": "M012",
      "brand_name_base": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML",
      "pharm_class": [
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Antagonist [EPC]"
      ]
    }
  ]
}