{
  "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,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL Diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE 903"
      ],
      "spl_unclassified_section": [
        "​Drug Facts",
        "*Compare to the Active Ingredient of Unisom ® SleepGels ® Helps Fall Asleep Fast READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY HY-VEE, INC. WEST DES MOINES, IA 50266 STVA0126 PRODUCT OF INDIA SATISFACTION GUARANTEED CALL 1-800-289-8343 www.hy-vee.com TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom®."
      ],
      "active_ingredient": [
        "​Active ingredient (in each softgel) Diphenhydramine HCl 50 mg"
      ],
      "purpose": [
        "​Purpose Nighttime sleep-aid"
      ],
      "indications_and_usage": [
        "​Uses • for relief of occasional sleeplessness"
      ],
      "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 • trouble urinating due to an enlarged prostate gland ​Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers ​When using this product avoid alcoholic drinks ​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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "​Directions • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor"
      ],
      "storage_and_handling": [
        "​Other information • store at 20-25°C (68-77° F) • keep bottle tightly closed • protect from light, heat and moisture"
      ],
      "inactive_ingredient": [
        "​Inactive ingredients FD&C blue no.1, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, titanium dioxide"
      ],
      "questions": [
        "​Questions or comments? ​1-888-577-8033 ​Monday-Friday 8am-4pm EST"
      ],
      "package_label_principal_display_panel": [
        "Packaging HyVeeMSNighttimeSleep-AidSOFTGEL"
      ],
      "set_id": "496ce4ba-08a9-ee99-e063-6294a90ac9a7",
      "id": "af9ee2b4-0e9f-407d-b560-a2708a879111",
      "effective_time": "20260821",
      "version": "2",
      "openfda": {
        "application_number": [
          "M010"
        ],
        "brand_name": [
          "HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "HyVee Inc"
        ],
        "product_ndc": [
          "42507-834"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1020477"
        ],
        "spl_id": [
          "af9ee2b4-0e9f-407d-b560-a2708a879111"
        ],
        "spl_set_id": [
          "496ce4ba-08a9-ee99-e063-6294a90ac9a7"
        ],
        "package_ndc": [
          "42507-834-64",
          "42507-834-32",
          "42507-834-96"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0075450856828"
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      }
    }
  ]
}