FDA.reportPublic FDA data

NASAL SPRAY ORIGINAL 15mL and 30mL

Manufacturer
Seaway Pharma Inc.
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:44

Label at a glance#

ProductOXYMETAZOLINE HCl
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

store between 20°C to 25°C (68° to 77° F) retain carton for future reference on full labeling

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Oxymetazoline HCl 0.05%

OTC - PURPOSE SECTION

Purpose: Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • shrinks swollen nasal membrances so you can breathe more freely.

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - DO NOT USE SECTION

When using this product:

  • do not use more than directed
  • do not use for more than 3 days. Use only as directed.

OTC - WHEN USING SECTION

  • 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 - PREGNANCY OR BREAST FEEDING SECTION

Stop use and ask a doctor If symptoms persist.

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill 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: consult a doctor.

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

STORAGE AND HANDLING SECTION

  • store between 20°C to 25°C (68° to 77° F)
  • retain carton for future reference on full labeling

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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

HOW SUPPLIED SECTION

(pack: 30ml)  NDC# 73414-002-02

(pack: 15ml) NDC# 73414-002-13

Manufactured by:

Seaway Pharma Inc.

Massena, NY 13662

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton30ml
Carton30ml
carton15ml
carton15ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73414-002-022022-01-28C16284748780-1d6a99b39-dd24-a426-e053-dadaa90af4c2NASAL SPRAY ORIGINAL 15mL and 30mL
73414-002-172022-01-28C16284748780-1d6a99b39-dd24-a426-e053-dadaa90af4c2NASAL SPRAY ORIGINAL 15mL and 30mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73414-002-02OXYMETAZOLINE HCl1 in 1 CARTONSPRAY12
73414-002-02OXYMETAZOLINE HCl30 mL in 1 BOTTLESPRAY302
73414-002-17OXYMETAZOLINE HCl1 in 1 CARTONSPRAY12
73414-002-17OXYMETAZOLINE HCl15 mL in 1 BOTTLESPRAY152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73414-002OXYMETAZOLINE HCL SPRAY [SEAWAY PHARMA INC.]2Legacy NDC, 4 package rows20200624_29042ff4-82b1-428e-81d2-0f86d73caec3.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
73414-00273414-002-02, 73414-002-17

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT

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
bc8cd053-70d3-45cf-8e1d-5b3edf833e5f29042ff4-82b1-428e-81d2-0f86d73caec32020-06-18WarningsExact identifier
spl id: bc8cd053-70d3-45cf-8e1d-5b3edf833e5f
spl set id: 29042ff4-82b1-428e-81d2-0f86d73caec3

Reported adverse events (FAERS/openFDA)#

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