FDA.reportPublic FDA data

OXYMETAZOLINE HYDROCHLORIDE

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC | Seaway Pharma Inc.
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:15

Label at a glance#

ProductOXYMETAZOLINE HYDROCHLORIDE
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 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 10-12 hours. Do not exceed 2 doses in any 24-hour period.  children under 6 years of age: ask a doctor Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and turn in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thu...

Storage and handling

store between 20° -25°C (68°-77 °F) retain carton for future reference on full labeling Questions or comments? 1-800-935-2362 (Mon-Fri 9am-5pm EST)

Label contents#

Full prescribing information#

Active Ingredient                         Purpose

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCI 0.05% ....... Nasal decongestant

OTC - PURPOSE SECTION

  • Rapid & Powerful Congestion Relief

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

Warnings Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - DO NOT USE 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

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 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period. 
  • children under 6 years of age: ask a doctor
  • Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and turn in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.

Other information

STORAGE AND HANDLING SECTION

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

Questions or comments?
1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive ingredients

INACTIVE INGREDIENT SECTION

avicel, benzalkonium chloride, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium dihydrate, eucalyptol, menthol, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bayer HealthCare LLC mdistributor of Afrin No Drip Severe Congestion

Distributed by C.D.M.A. lnc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-608-01OXYMETAZOLINE HYDROCHLORIDE30 mL in 1 BOTTLESOLUTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-608OXYMETAZOLINE HYDROCHLORIDE SOLUTION [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, Legacy NDC, 1 package rows20241228_aebc7cf8-aaf7-4746-89f5-a64d0be1641e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-608-01ML - Milliliter63868-6086a4acf18-6fe2-40d8-a741-601ccd37913c12023-06-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-60863868-608-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTOLRV6J6604TKIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT

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
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
ndc (package): 63868-608-01
ndc (product): 63868-608
ndc11 (package): 63868060801
spl id: fe2fd512-7a50-4341-a82e-30fdc9eea7c9
spl set id: aebc7cf8-aaf7-4746-89f5-a64d0be1641e

Reported adverse events (FAERS/openFDA)#

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