Label: NARCAN- naloxone hydrochloride nasal spray

  • NDC Code(s): 69547-627-02, 69547-627-05, 69547-627-06, 69547-627-24
  • Packager: Emergent Devices Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 17, 2026

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  • Active ingredient (in each spray)

    Naloxone Hydrochloride 4 mg

  • Purpose

    Emergency treatment of opioid overdose

  • Uses

    • to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin
    • this medicine can save a life
  • Warning

    • When using this productsome people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.
  • 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
    		Naloxone HCl Nasal Spray 4 mg
    1. Check

    Step 1: CHECK if you suspect an overdose:

    • CHECKfor 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
    2. Give

    Step 2: Give 1 stdose in the nose

    • HOLDthe nasal spray device with your thumb on the bottom of the plunger
    • INSERTthe nozzle into either NOSTRIL
    • PRESSthe plunger firmly to give the 1st dose
    • 1 nasal spray device contains 1 dose
    3. Call

    Step 3: CALL 911

    • CALL 911immediately after giving the l stdose
    4. Watch/Give

    Step 4: WATCH & GIVE

    • WAIT2-3 minutes after the l stdose 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 GIVEdoses every 2-3 minutes until the person wakes up
      • it is safe to keep giving doses
    5. Stay

    Step 5: STAY

    • STAYuntil ambulance arrives: even if the person wakes up
    • GIVEanother 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.
  • Inactive Ingredients

    benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

  • Questions?

    Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com

  • Package/Label Principal Display Panel – Carton Label

    Narcan Naloxone HCl Nasal Spray 4 mg Carton Label
  • Package/Label Principal Display Panel - 4 mg Vial Package

    Narcan Naloxone HCl Nasal Spray 4 mg Vial Carton Label
  • Package/Label Principal Display Panel – Front and Back Label

    Narcan Naloxone HCl Nasal Spray 4 mg Vial Label
  • Package/Label Principal Display Panel – Carrying Case Label

    Package/Label Principal Display Panel – Carrying Case Label
  • Package/Label Principal Display Panel – Carrying Case Carton Label

    Package/Label Principal Display Panel – Carrying Case Carton Label
  • Package/Label Principal Display Panel – 6ct Carton Label

    Package/Label Principal Display Panel – 6ct Carton Label
  • Package/Label Principal Display Panel – 24ct Carton Label

    Package/Label Principal Display Panel – 24ct Carton Label
    Package/Label Principal Display Panel – 24ct Carton Label
  • INGREDIENTS AND APPEARANCE
    NARCAN 
    naloxone hydrochloride nasal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69547-627
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE4 mg  in 0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69547-627-051 in 1 CARTON03/15/2026
    12 in 1 CASE
    10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:69547-627-022 in 1 CARTON08/28/2023
    20.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:69547-627-066 in 1 CARTON03/15/2026
    30.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:69547-627-2424 in 1 CARTON03/15/2026
    40.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20841108/28/2023
    Labeler - Emergent Devices Inc. (079673287)
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