{
  "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,
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  },
  "results": [
    {
      "product_ndc": "49483-693",
      "generic_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels",
      "labeler_name": "TIME CAP LABORATORIES, INC.",
      "brand_name": "Daytime cold and flu",
      "active_ingredients": [
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/1"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "10 mg/1"
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      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "49483-693-48",
          "description": "4 BLISTER PACK in 1 CARTON (49483-693-48)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
          "marketing_start_date": "20230706",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "TIME CAP LABORATORIES, INC."
        ],
        "rxcui": [
          "1086997"
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        "spl_set_id": [
          "fd24653e-c4fa-3c09-e053-6394a90aaa9e"
        ],
        "is_original_packager": [
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        "unii": [
          "04JA59TNSJ",
          "362O9ITL9D",
          "9D2RTI9KYH"
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      "marketing_category": "OTC MONOGRAPH DRUG",
      "dosage_form": "CAPSULE, LIQUID FILLED",
      "spl_id": "2dc3a685-34e1-0823-e063-6294a90ad27d",
      "product_type": "HUMAN OTC DRUG",
      "route": [
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      "marketing_start_date": "20230706",
      "product_id": "49483-693_2dc3a685-34e1-0823-e063-6294a90ad27d",
      "application_number": "M012",
      "brand_name_base": "Daytime cold and flu",
      "pharm_class": [
        "Adrenergic alpha1-Agonists [MoA]",
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]",
        "alpha-1 Adrenergic Agonist [EPC]"
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}