NASAL SPRAY

Manufacturer
Bi-Mart | SEAWAY PHARMA
Effective date
2024-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:36

Label at a glance#

ProductNASAL
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely

Dosage and administration

adults and children 6 to under 12 years of age (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 under 6 years of age: ask a doctor. to spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Storage and handling

do not use if seal around cap is missing or damaged save carton for complete information store between 20° to 25°C (68°F and 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • do not use 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

OTC - STOP USE SECTION

Stop use and ask a doctor ifsymptoms persist.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 to under 12 years of age (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 under 6 years of age:ask a doctor.
  • to spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

STORAGE AND HANDLING SECTION

  • do not use if seal around cap is missing or damaged
  • save carton for complete information
  • store between 20° to 25°C (68°F and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride solution, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-935-6737

Distributed by:

SPL UNCLASSIFIED SECTION

BI-MART

Eugene, OR 97402

*This product is not manufactured or distributed by the owner of the registered trademark Afrin ®

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BI-MART

*Compare to the active ingredient in Afrin ®

LONG LASTING

NASAL SPRAY

Oxymetazoline hydrochloride 0.05%

NASAL DECONGESTANT

FAST CONGESTION RELIEF FOR UP TO 12 HOURS

RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES

1 FL. OZ. (30 mL)

11523-116711523-1167

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-995-34NASAL1 in 1 CARTONSPRAY11
37835-995-34NASAL30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-995NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BI-MART]12 package rows20240517_276e45f8-8c61-4253-aed7-af50df7e1bd7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37835-99537835-995-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
188bbb87-d83f-05bc-e063-6394a90acc8e276e45f8-8c61-4253-aed7-af50df7e1bd72024-05-16WarningsExact identifier
spl id: 188bbb87-d83f-05bc-e063-6394a90acc8e
spl set id: 276e45f8-8c61-4253-aed7-af50df7e1bd7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.