Label: NASALCROM- cromolyn sodium spray, metered

  • NDC Code(s): 52183-199-13, 52183-199-14
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 5, 2023

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  • Drug Facts

  • Active ingredient (per spray)

    Cromolyn sodium 5.2 mg

  • Purpose

    Nasal allergy symptom controller

  • Uses

    to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

    • runny/itchy nose
    • sneezing
    • allergic stuffy nose
  • Warnings

    For external use only

    Do not use

    if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • fever
    • discolored nasal discharge
    • sinus pain
    • wheezing

    When using this product

    • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
    • brief stinging or sneezing may occur right after use
    • do not use it to treat sinus infection, asthma, or cold symptoms
    • do not share this bottle with anyone else as this may spread germs

    Stop use and ask a doctor if

    • shortness of breath, wheezing, or chest tightness occurs
    • hives or swelling of the mouth or throat occurs
    • your symptoms worsen
    • you have new symptoms
    • your symptoms do not begin to improve within two weeks
    • you need to use for more than 12 weeks

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • see package insert on how to use pump
    • parent or care provider must supervise the use of this product by young children
    • adults and children 2 years and older:
      • spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
      • use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)
      • to preventnasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
      • if desired, you can use this product with other medicines, including other allergy medicines.
      • children under 2 years:Do not use unless directed by a doctor.
  • Other information

    • store between 20-25°C (68-77°F)
    • protect from light
    • keep carton and package insert. They contain important instructions.
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    benzalkonium chloride, edetate disodium, purified water

  • Questions or comments?

    Call toll-free 1-877-9-ALLERGY (1-877-925-5374)

    9226205

  • Principal Display Panel

    NASAL SPRAY

    NasalCrom ®

    cromolyn sodium nasal solution, USP

    NASAL ALLERGY

    SYMPTOM CONTROLLER

    PREVENTS
    & RELIEVES

    NASAL ALLERGY
    SYMPTOMS

    For Intranasal use only.

    • runny / itchy nose
    • sneezing
    • allergic stuffy nose

    ORIGINAL PRESCRIPTION STRENGTH

    Safe for ages 2+

    200 METERED SPRAYS

    Each spray delivers 5.2 mg cromolyn sodium

    0.88 FL OZ (26 mL) carton

  • INGREDIENTS AND APPEARANCE
    NASALCROM 
    cromolyn sodium spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-199
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM5.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-199-141 in 1 CARTON10/29/2009
    1100 in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:52183-199-131 in 1 CARTON10/29/2009
    2200 in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07570210/29/2009
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch Health Companies Inc.245141858manufacture(52183-199)
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