{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Sinufrin Quick Relief Decongestant Sinufrin BENZALKONIUM CHLORIDE SODIUM CHLORIDE OXYMETAZOLINE OXYMETAZOLINE EDETATE DISODIUM SODIUM BICARBONATE PROPYLENE GLYCOL WATER"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Oxymetazoline hydrochloride 0.04%"
      ],
      "purpose": [
        "Purpose Nasal Decongestant"
      ],
      "indications_and_usage": [
        "Uses: Temporarily relieves nasal congestion due to: Common cold Hay fever Upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen nasal membranes so you can breathe more freely"
      ],
      "warnings": [
        "Warnings Ask a doctor before use if you have Heart disease High blood pressure Diabetes Thyroid disease Trouble urinating due to an enlarged prostate gland"
      ],
      "when_using": [
        "When using this product Do not use more than directed Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur Use of this container by more than one person may spread infection."
      ],
      "stop_use": [
        "Warnings ​Stop use and ask a doctor if symptoms persist"
      ],
      "pregnancy_or_breast_feeding": [
        "Warnings If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Warnings Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 to under 12 years of age (with adult supervision): 3 or 4 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use."
      ],
      "other_safety_information": [
        "Other Information Store between 68° F (20° C) and 86° F (30° C) Retain carton for future reference on full labeling"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Sinufrin spray"
      ],
      "set_id": "0c36a34e-462d-713c-e063-6294a90a1776",
      "id": "0e913859-1a68-3915-e063-6394a90a7e63",
      "effective_time": "20240109",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Sinufrin Quick Relief Decongestant"
        ],
        "generic_name": [
          "SINUFRIN"
        ],
        "manufacturer_name": [
          "Neilmed pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-325"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OXYMETAZOLINE"
        ],
        "spl_id": [
          "0e913859-1a68-3915-e063-6394a90a7e63"
        ],
        "spl_set_id": [
          "0c36a34e-462d-713c-e063-6294a90a1776"
        ],
        "package_ndc": [
          "13709-325-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000192562",
          "N0000009908",
          "N0000175651",
          "M0461078"
        ],
        "pharm_class_epc": [
          "Vasoconstrictor [EPC]"
        ],
        "pharm_class_pe": [
          "Vasoconstriction [PE]",
          "Increased Sympathetic Activity [PE]"
        ],
        "pharm_class_cs": [
          "Imidazolines [CS]"
        ],
        "unii": [
          "8VLN5B44ZY"
        ]
      }
    }
  ]
}