{
  "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": [
    {
      "spl_product_data_elements": [
        "Nighttime Sleep Aid Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SOLUTION SUCRALOSE SUCROSE XANTHAN GUM Clear Purple"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each 30 mL dose cup) Diphenhydramine HCl 50 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 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 a 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 right away (1-800-222-1222)."
      ],
      "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",
        "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness."
      ],
      "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"
      ],
      "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 right away (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions take only one dose (30 mL) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\"><tbody><tr><td>adults &amp; children 12 yrs &amp; over</td><td>30 mL at bedtime if needed or as directed by a doctor</td></tr><tr><td><paragraph>children under 12 yrs</paragraph></td><td>do not use</td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information each 30 mL dose cup contains: sodium 23 mg store at no greater than 25°C"
      ],
      "inactive_ingredient": [
        "Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, sucrose, xanthan gum"
      ],
      "questions": [
        "Questions or comments? Call 1-800-632-6900"
      ],
      "package_label_principal_display_panel": [
        "Package Label Sleeve Label - Nighttime Sleep Aid diphenhydramine-hcl-24oz-sleeve"
      ],
      "set_id": "514aa6b5-c33b-494c-e063-6294a90a7ace",
      "id": "576e6ed3-5559-2480-e063-6294a90a02e6",
      "effective_time": "20260827",
      "version": "2",
      "openfda": {
        "application_number": [
          "M010"
        ],
        "brand_name": [
          "Nighttime Sleep Aid"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Kroger"
        ],
        "product_ndc": [
          "41226-793"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1248354"
        ],
        "spl_id": [
          "576e6ed3-5559-2480-e063-6294a90a02e6"
        ],
        "spl_set_id": [
          "514aa6b5-c33b-494c-e063-6294a90a7ace"
        ],
        "package_ndc": [
          "41226-793-01",
          "41226-793-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      }
    }
  ]
}