{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "EZ Nite Sleep Diphenhyramine Hydrochloride PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 SHELLAC WATER TITANIUM DIOXIDE FD&C RED NO. 40 GELATIN SORBITOL SOLUTION FD&C BLUE NO. 1 SORBITAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 121 oblong shaped Purple,translucent"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each softgel) Diphenhydramine HCl 25 mg"
      ],
      "purpose": [
        "Purpose Nighttime sleep-aid"
      ],
      "indications_and_usage": [
        "Uses ■ for the relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep"
      ],
      "warnings": [
        "Warnings Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin. Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product ■ avoid alcoholic beverages"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions ■ take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td>  adults &amp; children 12 yrs &amp; over  </td><td>2 softgels at bedtime if needed or as directed by a doctor</td></tr><tr><td>children under 12 yrs</td><td>do not use</td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information ■ store at 20-25° C (68-77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light"
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide."
      ],
      "questions": [
        "Questions or comments? Call 1-800-632-6900"
      ],
      "package_label_principal_display_panel": [
        "diphenhydramine-sg-24s-ifc"
      ],
      "set_id": "0fec16a4-b4eb-8f8f-e063-6394a90a7327",
      "id": "16443f3d-c881-1fe3-e063-6394a90a4e4d",
      "effective_time": "20240417",
      "version": "2",
      "openfda": {
        "application_number": [
          "M010"
        ],
        "brand_name": [
          "EZ Nite Sleep"
        ],
        "generic_name": [
          "DIPHENHYRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "KROGER COMPANY"
        ],
        "product_ndc": [
          "41226-613"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1049909"
        ],
        "spl_id": [
          "16443f3d-c881-1fe3-e063-6394a90a4e4d"
        ],
        "spl_set_id": [
          "0fec16a4-b4eb-8f8f-e063-6394a90a7327"
        ],
        "package_ndc": [
          "41226-613-24"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      }
    }
  ]
}