FDA.reportPublic FDA data

Afrin Original Nasal Spray

Manufacturer
Bayer HealthCare LLC.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductAfrin Original Nasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure8 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. Secure...

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.

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

SPL UNCLASSIFIED 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package4Outer Package4Inner Package4Inner Package4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000992Afrin 0.05 % Nasal SprayPSN3
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3
1000992Afrin 0.05 % Nasal SpraySY3
1000992Afrin 0.5 MG/ML Nasal SpraySY3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3

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
11523-1168-62023-02-03C16284748780-1c7ccaba7-110d-fd44-e053-dadaa90aa01bAfrin Original Nasal Spray
11523-1168-62021-07-23C16284748780-1c7ccaba7-110d-fd44-e053-dadaa90aa01bAfrin Original Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1168-6Afrin Original Nasal6 mL in 1 BOTTLESPRAY63
11523-1168-6Afrin Original Nasal6 in 1 BOXSPRAY63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1168AFRIN ORIGINAL NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]3Legacy NDC, 2 package rows20231106_af46c67d-f01f-83f8-e053-2a95a90aa70f.zip

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

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
11523-116811523-1168-6
11523-1167

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
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 · 2 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 (product): 11523-1167
09734a55-efc5-3b22-e063-6394a90ad2d2af46c67d-f01f-83f8-e053-2a95a90aa70f2023-11-05WarningsExact identifier
spl id: 09734a55-efc5-3b22-e063-6394a90ad2d2
spl set id: af46c67d-f01f-83f8-e053-2a95a90aa70f

Reported adverse events (FAERS/openFDA)#

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