Afrin

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:19:56

Label at a glance#

ProductAfrin Original
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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Storage and handling

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

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
  • 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

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 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor.

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-317-2165

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Afrin ®

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Original

NASAL SPRAY

Fast, Powerful

Congestion

Relief

Colds • Allergies

up to 12

Hour

Relief

Maximum

Strength

#1 Doctor & Pharmacist

Recommended Brand

1/2 FL OZ (15 mL)

11523-116711523-1167

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000992Afrin 0.05 % Nasal SprayPSN12
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN12
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD12
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD12
1000992Afrin 0.05 % Nasal SpraySY12
1000992Afrin 0.5 MG/ML Nasal SpraySY12
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY12

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
11523-1167-1AfrinOriginal6 mL in 1 BOTTLE, SPRAYSPRAY612
11523-1167-2AfrinOriginal21 mL in 1 BOTTLE, SPRAYSPRAY2112
11523-1167-2AfrinOriginal2 in 1 CARTONSPRAY212
11523-1167-3AfrinOriginal1 in 1 CARTONSPRAY112
11523-1167-3AfrinOriginal20 mL in 1 BOTTLE, SPRAYSPRAY2012
11523-1167-4AfrinOriginal3 in 1 CARTONSPRAY312
11523-1167-4AfrinOriginal30 mL in 1 BOTTLE, SPRAYSPRAY3012
11523-1167-5AfrinOriginal30 mL in 1 BOTTLE, SPRAYSPRAY3012
11523-1167-5AfrinOriginal1 in 1 CARTONSPRAY112
11523-1167-6AfrinOriginal15 mL in 1 BOTTLE, SPRAYSPRAY1512
11523-1167-6AfrinOriginal1 in 1 CARTONSPRAY112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-1167-3ML - Milliliter11523-1167e6b61680-eaad-4ff1-a0d4-d25116e1ada112015-10-02
11523-1167-5ML - Milliliter11523-1167892df7b8-5889-48d3-9cdf-70a8f33e8c4912013-10-17
11523-1167-6ML - Milliliter11523-11675797e12f-28cc-49e5-bfd1-5dc75045522c12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Oxymetazoline hydrochlorideACTIVE INGREDIENTK89MJ0S5VY2
OxymetazolineACTIVE MOIETY8VLN5B44ZY2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W72
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A2
povidonesINACTIVE INGREDIENTFZ989GH94E2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA742
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SW2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-116711523-1167-2, 11523-1167-3, 11523-1167-4, 11523-1167-5, 11523-1167-6, 11523-1167-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 392 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74SUSPENSION / OPHTHALMIC0.43 %w/wExact identifier — unii candidate
98 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
63 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74FILM, SOLUBLE / ORAL9 mgExact identifier — unii candidate
98 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAVENOUS161 mgExact identifier — unii candidate
63 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
98 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
63 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
210 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.2 mgExact identifier — unii candidate
63 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74CONCENTRATE / ORAL17 mg/5mlExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
63 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS40 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74FILM, SOLUBLE / ORAL9 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
98 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, SUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
63 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2.98 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS40 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii candidate
98 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
210 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
63 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium phosphate, dibasicSODIUM PHOSPHATE, DIBASICGR686LBA74TABLET, EXTENDED RELEASE / ORAL143 mgExact identifier — unii candidate
98 equally ranked IID candidates
sodium phosphate, monobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
63 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
210 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
210 equally ranked IID candidates

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 OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
ndc (package): 11523-1167-2
ndc (package): 11523-1167-1
ndc (package): 11523-1167-4
ndc (package): 11523-1167-3
ndc (package): 11523-1167-5
ndc (package): 11523-1167-6
ndc (product): 11523-1167
ndc11 (package): 11523116705
ndc11 (package): 11523116702
ndc11 (package): 11523116703
ndc11 (package): 11523116701
ndc11 (package): 11523116706
ndc11 (package): 11523116704
spl id: 452362c1-c953-c5d7-e063-6294a90ad7c4
spl set id: 89c165ba-3ad5-49b5-a5bb-423dc8e15bad

Reported adverse events (FAERS/openFDA)#

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