{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sleepy Time CP Aconitum, Arsenicum Alb, Calc Carb, Coffea Cruda, Magnesium Met, Nux Vom, Pulsatilla, Sepia, Sulphur ACONITUM NAPELLUS WHOLE ACONITUM NAPELLUS ARSENIC TRIOXIDE ARSENIC CATION (3+) OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE ARABICA COFFEE BEAN ARABICA COFFEE BEAN MAGNESIUM MAGNESIUM STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PULSATILLA VULGARIS WHOLE ANEMONE PULSATILLA SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE SULFUR SULFUR CITRIC ACID MONOHYDRATE GLYCERIN POTASSIUM SORBATE WATER"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X"
      ],
      "indications_and_usage": [
        "USES: Temporarily relieves occasional sleeplessness.**"
      ],
      "purpose": [
        "USES: Temporarily relieves occasional sleeplessness.**"
      ],
      "dosage_and_administration": [
        "DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF THE REACH OF CHILDREN . In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away."
      ],
      "warnings": [
        "WARNINGS: IF PREGNANT OR BREAST-FEEDING , ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. Do not use if TAMPER EVIDENT seal is broken or missing."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Natural Cherry Flavor, Potassium Sorbate, Purified Water"
      ],
      "questions": [
        "QUESTIONS & COMMENTS? Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600"
      ],
      "references": [
        "*The letters \"HPUS\" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
      ],
      "package_label_principal_display_panel": [
        "NDC:43406-0675-1 Sleepy Time CP HOMEOPATHIC 1 fl oz (30mL) / Alcohol Free image description"
      ],
      "set_id": "03cbb408-7e2a-49e8-b83a-b8d932a10459",
      "id": "b30c6c13-693d-4b4a-b6f6-e1a0f196c1c4",
      "effective_time": "20251216",
      "version": "2",
      "openfda": {
        "brand_name": [
          "Sleepy Time CP"
        ],
        "generic_name": [
          "ACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHUR"
        ],
        "manufacturer_name": [
          "Natural Creations, Inc"
        ],
        "product_ndc": [
          "43406-0675"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACONITUM NAPELLUS WHOLE",
          "ARSENIC TRIOXIDE",
          "OYSTER SHELL CALCIUM CARBONATE, CRUDE",
          "ARABICA COFFEE BEAN",
          "MAGNESIUM",
          "STRYCHNOS NUX-VOMICA SEED",
          "PULSATILLA VULGARIS WHOLE",
          "SEPIA OFFICINALIS JUICE",
          "SULFUR"
        ],
        "spl_id": [
          "b30c6c13-693d-4b4a-b6f6-e1a0f196c1c4"
        ],
        "spl_set_id": [
          "03cbb408-7e2a-49e8-b83a-b8d932a10459"
        ],
        "package_ndc": [
          "43406-0675-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0877730002716"
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "M0516536",
          "N0000185001"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]",
          "Seed Storage Proteins [CS]"
        ],
        "unii": [
          "U0NQ8555JD",
          "S7V92P67HO",
          "2E32821G6I",
          "3SW678MX72",
          "I38ZP9992A",
          "269XH13919",
          "I76KB35JEV",
          "QDL83WN8C2",
          "70FD1KFU70"
        ]
      }
    }
  ]
}