{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Ultra Fine Mist Sinus Relief Oxymetazoline Hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL CAMPHOR (NATURAL) EDETATE DISODIUM EUCALYPTOL MENTHOL, UNSPECIFIED FORM POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM Clear"
      ],
      "active_ingredient": [
        "Active ingredient Oxymetazoline hydrochloride 0.05%"
      ],
      "purpose": [
        "Purpose Nasal Decongestant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves ▪ nasal congestion due to a cold, heavy fever, or other upper respiratory allergies ▪ sinus congestion and pressure"
      ],
      "warnings": [
        "Warnings"
      ],
      "ask_doctor": [
        "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 exceed recommended dosage ▪ do not use this product 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": [
        "Stop use and ask a doctor if • symptoms persist"
      ],
      "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. If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions ▪ adults & children 6 to under 12 years of age & older (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. ▪ children 2 to under 6 years: ask a doctor ▪ children 2 years: do not use To Use: Shake well before use . Push down cap while turning counter-clockwise and remove cap . Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use."
      ],
      "storage_and_handling": [
        "Other information ▪ store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic."
      ],
      "questions": [
        "Questions or comments? 1-866-467-2748"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel NDC# 55910-627-30 Compare to the active ingredient in Vicks® Sinex™ Severe Original* ULTRA FINE MIST SINUS RELIEF Oxymetazoline HCl Nasal Decongestant Original • Fast Sinus Congestion & Pressure Relief 12 Hour Pump Mist 1 FL OZ (30 mL) IMPORTANT: Keep the carton for future reference on full labeling Distributed by: *This product is not manufactured or distributed by Procter and Gamble, the distributer of Vicks ® Sinex™ Severe Original Ultra Fine Mist Sinus Relief"
      ],
      "package_label_principal_display_panel_table": [
        "<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">IMPORTANT:</content> Keep the carton for future reference on full labeling</paragraph></td></tr></tbody></table>"
      ],
      "set_id": "5f134840-2465-4585-a85d-08d746f76f7a",
      "id": "a09bbef7-050d-4d10-9baa-c9549d85850b",
      "effective_time": "20260903",
      "version": "7",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Ultra Fine Mist Sinus Relief"
        ],
        "generic_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "DOLGENCORP, INC."
        ],
        "product_ndc": [
          "55910-627"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "OXYMETAZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1000990"
        ],
        "spl_id": [
          "a09bbef7-050d-4d10-9baa-c9549d85850b"
        ],
        "spl_set_id": [
          "5f134840-2465-4585-a85d-08d746f76f7a"
        ],
        "package_ndc": [
          "55910-627-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K89MJ0S5VY"
        ]
      }
    }
  ]
}