FDA.reportPublic FDA data

Afrin Allergy Sinus Nasal Spray UI1612342

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:20:04

Label at a glance#

ProductAfrin Allergy Sinus Nasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 SAFETY INFORMATION

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • retain carton for future reference on full labeling

INACTIVE INGREDIENT SECTION

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

OTC - QUESTIONS SECTION

Questions or comments? 1-800-317-2165

15 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Afrin

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Allergy Sinus

Nasal Spray

Fast, Powerful

Congestion

Relief From

Allergies

up to

12 HOUR

RELIEF

Reduces

Swelling of

Nasal

Packages

#1 Doctor &

Pharmacist Recommended

Nasal Spray Brand

1/2 FL OZ (15 mL)

11523-007311523-0073

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000992Afrin 0.05 % Nasal SprayPSN7
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN7
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD7
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD7
1000992Afrin 0.05 % Nasal SpraySY7
1000992Afrin 0.5 MG/ML Nasal SpraySY7
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY7

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0073-1Afrin Allergy Sinus Nasal1 in 1 CARTONSPRAY17
11523-0073-1Afrin Allergy Sinus Nasal15 mL in 1 BOTTLESPRAY157

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
11523-007311523-0073-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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

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
Afrin Allergy Sinus NasalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.c2d903bf-5c51-82d7-e053-2995a90aea492025-12-04WarningsExact identifier
ndc (package): 11523-0073-1
ndc (product): 11523-0073
ndc11 (package): 11523007301
spl id: 4526cefb-c0f2-f77d-e063-6294a90a59be
spl set id: c2d903bf-5c51-82d7-e053-2995a90aea49

Reported adverse events (FAERS/openFDA)#

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