{
  "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": "2026-06-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Acetaminophen and Diphenhydramine citrate Acetaminophen and Diphenhydramine citrate HYPROMELLOSES MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 FD&C BLUE NO. 2 FD&C BLUE NO. 1 CELLULOSE, MICROCRYSTALLINE STARCH, CORN POVIDONE K30 DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE SILICON DIOXIDE S26"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF THE REACH OF CHILDREN"
      ],
      "indications_and_usage": [
        "Analgesic and Antipyretic"
      ],
      "dosage_and_administration": [
        "FOR MANUFACTURING, PROCESSING OR REPACKING"
      ],
      "warnings": [
        "KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE"
      ],
      "inactive_ingredient": [
        "Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose"
      ],
      "purpose": [
        "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Label"
      ],
      "set_id": "403a88fa-e06b-9b6e-e063-6394a90a97b8",
      "id": "403a87a6-fe92-8e79-e063-6394a90a70ce",
      "effective_time": "20251002",
      "version": "4",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Acetaminophen and Diphenhydramine citrate"
        ],
        "generic_name": [
          "ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE"
        ],
        "manufacturer_name": [
          "InvaTech Pharma Solutions LLC"
        ],
        "product_ndc": [
          "57631-010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DIPHENHYDRAMINE CITRATE"
        ],
        "rxcui": [
          "1099872"
        ],
        "spl_id": [
          "403a87a6-fe92-8e79-e063-6394a90a70ce"
        ],
        "spl_set_id": [
          "403a88fa-e06b-9b6e-e063-6394a90a97b8"
        ],
        "package_ndc": [
          "57631-010-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "4OD433S209"
        ]
      }
    }
  ]
}