Major Nasal Decongestant Spray

Manufacturer
Major Pharmaceuticals
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:09

Label at a glance#

ProductMajor Nasal Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiratory allergies shrinks swollen 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 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 backwards while spraying, wipe nozzle clean after use.

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCL 0.05%

Purpose 

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • 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
  • thyroid disease
  • trouble urinating due to enlarged prostate 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 - DO NOT USE SECTION

Symptoms persist

OTC - PREGNANCY OR BREAST FEEDING 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

  • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other information 

OTHER SAFETY INFORMATION

  • 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, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal Display Panel 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major© Original Nasal Spray NDC 0904-7435-35
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant
1/2 FLOZ (15ML)

760100_15ml_FrontLabel760100_15ml_FrontLabel

7496599_15ml_Carton7496599_15ml_Carton

760101_15ml_BackLabel760101_15ml_BackLabel

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7435-35Major Nasal Decongestant15 mL in 1 BOTTLE, SPRAYSPRAY152
0904-7435-35Major Nasal Decongestant1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7435MAJOR NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20231231_edb49b17-06a7-4c25-bc7c-d62c1deac7f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7435-35ML - Milliliter0904-7435955eff39-c5c2-4214-995a-2f1239c4859612024-07-12

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-74350904-7435-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
ndc (package): 0904-7435-35
ndc (product): 0904-7435
ndc11 (package): 00904743535
spl id: 22987538-bbaf-4dce-ba33-325abacdec70
spl set id: edb49b17-06a7-4c25-bc7c-d62c1deac7f1

Reported adverse events (FAERS/openFDA)#

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