oxymetazoline hcl

Manufacturer
A-S Medication Solutions
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:37:53

Label at a glance#

Productoxymetazoline hcl
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure10 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 Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Sec...

Storage and handling

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

Label contents#

Full prescribing information#

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
  • diabetes
  • thyroid disease
  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4308

NDC: 50090-4308-0 30 mL in a BOTTLE, SPRAY / 1 in a CARTON

oxymetazoline hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN8
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD8
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY8

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
50090-4308-02023-02-07C16284748780-1f386c649-b0e5-0266-e053-dadaa90a7c1aOxymetazoline HCl 0.05% Drug Facts
50090-4308-02023-01-30C16284748780-1f386c649-b0e5-0266-e053-dadaa90a7c1aOxymetazoline HCl 0.05% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4308-0oxymetazoline hcl1 in 1 CARTONSPRAY18
50090-4308-0oxymetazoline hcl30 mL in 1 BOTTLE, SPRAYSPRAY308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4308OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20241120_e51dfb62-40d0-4bec-9574-90057cb35bcc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4308-0ML - Milliliter50090-4308bac42324-aa3c-45ed-83a5-966c627a52cb12022-07-06
45802-410-59ML - Milliliter45802-41054e747ad-1a30-4db2-8182-ca670b35ec2512012-07-24

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
50090-430850090-4308-0
45802-410

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionse51dfb62-40d0-4bec-9574-90057cb35bcc2024-11-06WarningsExact identifier
ndc (package): 50090-4308-0
ndc (product): 50090-4308
ndc11 (package): 50090430800
spl id: e8fc976d-1df5-4099-b322-6ddca6504692
spl set id: e51dfb62-40d0-4bec-9574-90057cb35bcc
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltda1103cd8-344b-4a65-8a60-3c7be86d01a62024-09-11WarningsExact identifier
ndc (product): 45802-410

Reported adverse events (FAERS/openFDA)#

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