FDA.reportPublic FDA data

Oxymetazoline Hydrochloride

Manufacturer
Dynamic Pharmaceuticals
Effective date
2009-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:12

Label at a glance#

ProductOxymetazoline Hydrochloride
Active ingredientOxymetazoline Hydrochloride
Label structure10 sections

Indications and uses

Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies helps clear nasal passages shrinks swollen membranes temporarily relieves sinus congestion and pressure

Dosage and administration

adults and children 6-12 years of age (with adult supervision): Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use. Do not use more often than once 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 use pump: Remove cap and safety clip. Hold with thumb at bottom of bottle and nozzle between finger...

Storage and handling

Retain carton for future reference on full labeling Remove lock ring before each use

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
  • helps clear nasal passages
  • shrinks swollen membranes
  • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

For nasal use only.

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 result
  • use of this container by more than one person may spread infection

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms 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 6-12 years of age (with adult supervision): Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use.
  • Do not use more often than once 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 use pump:

  • Remove cap and safety clip.
  • Hold with thumb at bottom of bottle and nozzle between fingers.
  • Before using the first time, prime pump by depressing several times.

Other Information

STORAGE AND HANDLING SECTION

  • Retain carton for future reference on full labeling
  • Remove lock ring before each use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis gel, d-alpha-tocopherol-ester, disodium EDTA, disodium phosphate, ethylene & propylene oxide copolymer, eucalyptol, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, potassium sorbate, purified water

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 15 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS®
pharmacy

Compare to the active
ingredient in Zicam®*

NEW!

Maximum
SINUS RELIEF
NO DRIP NASAL GEL
OXYMETAZOLINE HCl 0.05%

Quickly relieves sinus
pressure & nasal congestion

  • Long-lasting
  • Non-drowsy

12
Hour
Relief

Menthol Eucalyptus

0.5 FL OZ (15mL)

Principal Display Panel - 15 mL Carton
Principal Display Panel - 15 mL Carton

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64762-864-152019-10-21C16284748780-1956f9ecf-d6ec-621f-e053-dbdaa90a74adCVS ® pharmacy
64762-864-222019-10-21C16284748780-1956f9ecf-d6ec-621f-e053-dbdaa90a74adCVS ® pharmacy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64762-864-15Oxymetazoline Hydrochloride15 mL in 1 BOTTLE, PUMPSPRAY, METERED151
64762-864-15Oxymetazoline Hydrochloride1 in 1 CARTONSPRAY, METERED11
64762-864-22Oxymetazoline Hydrochloride1 in 1 CARTONSPRAY, METERED11
64762-864-22Oxymetazoline Hydrochloride22 mL in 1 BOTTLE, PUMPSPRAY, METERED221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64762-864OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [DYNAMIC PHARMACEUTICALS]1Legacy NDC, 4 package rows20100112_c82f6cb6-28dd-4a26-9456-225ec61e82d2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VY1
OxymetazolineACTIVE MOIETY8VLN5B44ZY1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64762-86464762-864-15, 64762-864-22

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Oxymetazoline HydrochlorideK89MJ0S5VYACTIB

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
87057c78-4215-4840-a11b-82d7aa9f66e3c82f6cb6-28dd-4a26-9456-225ec61e82d22009-12-30WarningsExact identifier
spl id: 87057c78-4215-4840-a11b-82d7aa9f66e3
spl set id: c82f6cb6-28dd-4a26-9456-225ec61e82d2

Reported adverse events (FAERS/openFDA)#

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