{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0121-0775",
      "generic_name": "Guaifenesin and Codeine Phosphate",
      "labeler_name": "PAI Holdings, LLC",
      "dea_schedule": "CV",
      "brand_name": "Guaifenesin and Codeine Phosphate",
      "active_ingredients": [
        {
          "name": "GUAIFENESIN",
          "strength": "100 mg/5mL"
        },
        {
          "name": "CODEINE PHOSPHATE",
          "strength": "10 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0121-0775-04",
          "description": "118 mL in 1 BOTTLE (0121-0775-04)",
          "marketing_start_date": "20061001",
          "sample": false
        },
        {
          "package_ndc": "0121-0775-16",
          "description": "473 mL in 1 BOTTLE (0121-0775-16)",
          "marketing_start_date": "20061001",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "PAI Holdings, LLC"
        ],
        "rxcui": [
          "995868"
        ],
        "spl_set_id": [
          "88d0994c-4270-4408-8837-bd97510b2118"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193956",
          "N0000008867",
          "N0000009560"
        ],
        "pharm_class_epc": [
          "Expectorant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Respiratory Secretion Viscosity [PE]",
          "Increased Respiratory Secretions [PE]"
        ],
        "unii": [
          "GSL05Y1MN6",
          "495W7451VQ"
        ]
      },
      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "SOLUTION",
      "spl_id": "2175415b-f07e-50a6-e063-6394a90acabe",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20061001",
      "product_id": "0121-0775_2175415b-f07e-50a6-e063-6394a90acabe",
      "application_number": "M012",
      "brand_name_base": "Guaifenesin and Codeine Phosphate",
      "pharm_class": [
        "Decreased Respiratory Secretion Viscosity [PE]",
        "Expectorant [EPC]",
        "Full Opioid Agonists [MoA]",
        "Increased Respiratory Secretions [PE]",
        "Opioid Agonist [EPC]"
      ]
    }
  ]
}