{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "NARCAN naloxone hydrochloride nasal BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE WATER HYDROCHLORIC ACID NALOXONE HYDROCHLORIDE NALOXONE"
      ],
      "active_ingredient": [
        "Active ingredient (in each spray) Naloxone Hydrochloride 4 mg"
      ],
      "purpose": [
        "Purpose Emergency treatment of opioid overdose"
      ],
      "indications_and_usage": [
        "Uses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life"
      ],
      "warnings": [
        "Warning When using this product some people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN"
      ],
      "dosage_and_administration": [
        "Directions NARCAN ® Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Important: For use in the nose only Do not test nasal spray device before use 1 nasal spray device contains 1 dose of medicine Each device sprays 1 time only Step 1: CHECK if you suspect an overdose: CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing well yell “Wake up!” shake the person gently if the person is not awake, go to Step 2 Step 2: Give 1st dose in the nose HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose Step 3: CALL 911 CALL 911 immediately after giving the l st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the l st dose to give the medicine time to work if the person wakes up : Go to Step 5 if the person does not wake up : CONTINUE TO GIVE doses every 2-3 minutes until the person wakes up it is safe to keep giving doses Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another dose if the person becomes very sleepy again You may need to give all the doses in the pack For opioid emergencies, call 911. For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com . ©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries. Other Information store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) do not freeze avoid excessive heat above 40°C (104°F) protect from light the product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged. Naloxone HCl Nasal Spray 4 mg 1. Check 2. Give 3. Call 4. Watch/Give 5. Stay"
      ],
      "dosage_and_administration_table": [
        "<table width=\"0pt\" styleCode=\"Noautorules\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td valign=\"top\"><paragraph><content styleCode=\"bold\">Emergency Treatment of Opioid Overdose</content></paragraph><paragraph><content styleCode=\"bold\"/></paragraph><paragraph><content styleCode=\"bold\">Important:</content></paragraph><list listType=\"unordered\"><item>For use in the nose only</item><item>Do not test nasal spray device before use</item><item>1 nasal spray device contains 1 dose of medicine</item><item>Each device sprays 1 time only</item></list></td><td align=\"center\" valign=\"middle\"><renderMultiMedia ID=\"id-543673350\" referencedObject=\"ID_02ceb8b7-064b-451b-9fa0-9c146f71d163\"/></td></tr></tbody></table>",
        "<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"21%\"/><col width=\"77%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><list listType=\"unordered\"><item><content styleCode=\"bold\"><renderMultiMedia ID=\"id-2016682462\" referencedObject=\"ID_2fe990df-c052-430b-b33c-1d86b13a6ffa\"/></content></item></list></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1: CHECK if you suspect an overdose:</content></paragraph><list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">CHECK</content></content>for a <content styleCode=\"underline\">suspected overdose:</content>the person will not wake up or is very sleepy or not breathing well <list listType=\"unordered\"><item>yell &#x201C;Wake up!&#x201D;</item><item>shake the person gently</item><item>if the person is not awake, go to Step 2</item></list></item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><list listType=\"unordered\"><item><content styleCode=\"bold\"><renderMultiMedia ID=\"id-1999264217\" referencedObject=\"ID_165fde3b-736f-4f6f-b381-d667a71d06fe\"/></content></item></list></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2: Give 1st dose in the nose</content></paragraph><list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">HOLD</content></content>the nasal spray device with your thumb on the bottom of the plunger </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">INSERT</content></content>the nozzle into either NOSTRIL </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">PRESS</content></content>the plunger firmly to give the 1st dose </item><item>1 nasal spray device contains 1 dose</item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><list listType=\"unordered\"><item><content styleCode=\"bold\"><renderMultiMedia ID=\"id-72901077\" referencedObject=\"AEA3EA3D-6136-45BE-8653-6FCA4F961615\"/></content></item></list></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3: CALL 911</content></paragraph><list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">CALL 911</content></content>immediately after giving the l <sup>st</sup>dose </item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item><content styleCode=\"bold\"><renderMultiMedia ID=\"id-249734719\" referencedObject=\"ID_5329290d-316c-49d1-a8e8-a93804980a21\"/></content></item></list></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4: WATCH &amp; GIVE</content></paragraph><list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">WAIT</content></content>2-3 minutes after the l <sup>st</sup>dose to give the medicine time to work </item><item>if the person <content styleCode=\"underline\">wakes up</content>: Go to Step 5 </item><item>if the person does <content styleCode=\"underline\">not wake up</content>: <list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">CONTINUE TO GIVE</content></content>doses every 2-3 minutes until the person wakes up </item><item>it is safe to keep giving doses</item></list></item></list></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><content styleCode=\"bold\"><renderMultiMedia ID=\"id-1492702578\" referencedObject=\"ID_8a3767e7-3518-46e8-ada9-7f7a20a3bf21\"/></content></item></list></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5: STAY</content></paragraph><list listType=\"unordered\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">STAY</content></content>until ambulance arrives: even if the person wakes up </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">GIVE</content></content>another dose if the person becomes very sleepy again </item><item>You may need to give all the doses in the pack</item></list></td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water"
      ],
      "questions": [
        "Questions? Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel 1"
      ],
      "set_id": "3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92",
      "id": "50317ec7-5f58-b35a-e063-6394a90a7303",
      "effective_time": "20260424",
      "version": "2",
      "openfda": {
        "application_number": [
          "NDA208411"
        ],
        "brand_name": [
          "NARCAN"
        ],
        "generic_name": [
          "NALOXONE HYDROCHLORIDE NASAL"
        ],
        "manufacturer_name": [
          "Sportpharm LLC"
        ],
        "product_ndc": [
          "85766-076"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "NASAL"
        ],
        "substance_name": [
          "NALOXONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1725059",
          "1725064"
        ],
        "spl_id": [
          "50317ec7-5f58-b35a-e063-6394a90a7303"
        ],
        "spl_set_id": [
          "3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92"
        ],
        "package_ndc": [
          "85766-076-02"
        ],
        "original_packager_product_ndc": [
          "69547-627"
        ],
        "unii": [
          "F850569PQR"
        ]
      }
    }
  ]
}