FDA.reportPublic FDA data

Severe Nasal Spray

Manufacturer
Walgreens Company
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:38

Label at a glance#

ProductSevere Sinus Relief Mist
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Tempoarily relieves nasal congestion due to: common cold hay fever upper respiroty allergies temporaily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely

Dosage and administration

Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply. Wipe nozzle clean after use. Adults and children 6 to under 12 years of age (with a...

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

When using this product

OTC - WHEN USING SECTION

  • Do not use more than directed
  • do not use for more than three 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.

stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist.

if pregnant or breast-feeding 

PREGNANCY SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Benzyl Alcohol, Citric Acid Anhydrous, Edetate Sodium, Fragrance, Polysorbate 80, Purified Water, Sodium Citrate, Sorbitol

Principal Panel 0.5 FLOZ Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Panel 0.5 FLOZ BottlePrincipal Panel 0.5 FLOZ Bottle

Walgreens Severe Sinus Relief Mist

Nasal Spray 

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal Panel 0.5 FLOZ BottlePrincipal Panel 0.5 FLOZ Bottle

Principal Panel 0.5 FLOZ BottlePrincipal Panel 0.5 FLOZ Bottle

Principal Panel 0.5 FLOZ BottlePrincipal Panel 0.5 FLOZ Bottle

Principal Panel 0.5 FLOZ BottlePrincipal Panel 0.5 FLOZ Bottle

Principal display panel -Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Severe Sinus Relief Mist

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal display panel -CartonPrincipal display panel -Carton

Principal display panel -CartonPrincipal display panel -Carton

Principal display panel -CartonPrincipal display panel -Carton

Principal display panel -CartonPrincipal display panel -Carton

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
0363-2305-522024-02-14C16284748780-1d6a99b39-4438-a426-e053-dadaa90af4c2Severe Nasal Spray
0363-2305-522022-01-28C16284748780-1d6a99b39-4438-a426-e053-dadaa90af4c2Severe Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2305-52Severe Sinus Relief Mist15 mL in 1 BOTTLE, SPRAYLIQUID152
0363-2305-52Severe Sinus Relief Mist1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2305SEVERE SINUS RELIEF MIST (OXYMETAZOLINE SPRAY) LIQUID [WALGREENS COMPANY]2Current NDC, Legacy NDC, 2 package rows20240215_847f47d9-62b1-49a3-8bb3-9bf275685bd2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-23050363-2305-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
POLYSORBATE 806OZP39ZG8HIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
BENZYL ALCOHOLLKG8494WBHIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
EUCALYPTOLRV6J6604TKIACT

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
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
ndc (package): 0363-2305-52
ndc (product): 0363-2305
ndc11 (package): 00363230552
spl id: 01b9d6d6-4ab2-4f05-a037-b6114d1dc059
spl set id: 847f47d9-62b1-49a3-8bb3-9bf275685bd2

Reported adverse events (FAERS/openFDA)#

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