{
  "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": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Allergy DyeFree Allergy DyeFree DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SOLUTION Clear PC4"
      ],
      "active_ingredient": [
        "Active ingredient(s) Diphenhydramine HCl 25 mg"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing"
      ],
      "warnings": [
        "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if 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 taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Pregnancy/Breastfeeding 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 to make a child sleepy with any other product containing diphenhydramine, even one used on skin"
      ],
      "ask_doctor": [
        "Ask a doctor before use if a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"
      ],
      "pregnancy_or_breast_feeding": [
        "Pregnancy/Breastfeeding 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 every 4 to 6 hours do not take more than 6 doses in 24 hours Adults and children 12 years and over: 1 to 2 softgels Children 6 to under 12 years: 1 softgel Children under 6 years: do not use this product in children under 6 years of age"
      ],
      "spl_unclassified_section": [
        "Other information do not use if blister is torn or broken"
      ],
      "storage_and_handling": [
        "Storage store between 20-25 °C (68-77 °F). Avoid high humidity and excessive heat. Protect from light."
      ],
      "inactive_ingredient": [
        "Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink"
      ],
      "questions": [
        "Questions Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Diphenhydramine HCL 25mg Diphenhydramine HCL 25mg"
      ],
      "set_id": "15736bb8-5a5b-489d-83ad-4cf34ec62956",
      "id": "681dea0e-f646-4966-8649-54ba9aff1159",
      "effective_time": "20210426",
      "version": "2",
      "openfda": {
        "application_number": [
          "M009"
        ],
        "brand_name": [
          "Allergy DyeFree"
        ],
        "generic_name": [
          "ALLERGY DYEFREE"
        ],
        "manufacturer_name": [
          "Allegiant Health"
        ],
        "product_ndc": [
          "69168-409"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1049909"
        ],
        "spl_id": [
          "681dea0e-f646-4966-8649-54ba9aff1159"
        ],
        "spl_set_id": [
          "15736bb8-5a5b-489d-83ad-4cf34ec62956"
        ],
        "package_ndc": [
          "69168-409-86"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      }
    }
  ]
}