Label: SALINE- nasal spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 25, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Sodium Chloride 0.65%

  • Purpose 

    Moisturizer

  • Uses

    Naturally provides instant, soothing relief dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.

  • Warnings

    If pregnant or breast-feeding, ask a healthcare professional before use. Use of this container by more than one person may spread infection.

  • Keep out of reach of children.

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

  • Directions

    For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by physician. For infants, use drop application. Hold bottle upright for spray, horizontally for stream, and upside down for drop. The use of this dispenser by more than one person may spread infection.

  • Other Information

    store at room temperature

  • Inactive Ingredients

    benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or comments?

    1-866-467-2748

    *This product is not manufactured or distributed by Valeant Pharmaceuticals North America LLC, sodium phosphate monobasic.

  • Saline Nasal Spray 

    Compare to the active ingredient in Ocean®*

    Saline Nasal Spray

    Sodium Chloride 0.65%

    •
    Instantly relieves dry nasal passages caused by sinus, cold and allergy medications and dry air
    •
    Safe for frequent daily use
    •
    Gentle enough for infants
    •
    Natural, non-medicated relief for stuffy noses

    100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL AROUND CAP IS BROKEN OR MISSING.

    Distributed by:

    Package label for 44 mL

    DDM Choice Saline Nasal Spray 44 mL

    Package Label for 88 mL

    DDM Choice Saline Nasal Spray Pack size 88mL
  • INGREDIENTS AND APPEARANCE
    SALINE 
    nasal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-704
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-704-151 in 1 CARTON09/30/2020
    144 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:53943-704-301 in 1 CARTON09/30/2020
    288 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/2020
    Labeler - DISCOUNT DRUG MART, INC. (047741335)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!