FDA.reportPublic FDA data

Afrin Original

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:46

Label at a glance#

ProductAfrin Original
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure11 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. Secure cap after use.

Storage and handling

store between 20° to 25°C (68° to 77°F) retain card 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. Secure cap after use.

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • retain card 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

PDP/PACKAGE - 6 mL Bottle Blister Pack, Lil' Drug Store

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Doctor & Pharmacist
Recommended Brand

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Afrin ® Original

NASAL SPRAY

  • Relieves Nasal Congestion &

Sinus Congestion/Pressure

UNBLOCKS IN

SECONDS*

LASTS 12 HRS

*It unblocks your nose in

seconds, providing 12 hours of

nasal congestion relief without

drowsiness, so you can breathe

more freely all day or all night

[Bayer cross]

[Lil' Drug Store logo]

1/5 FL OZ

(6mL)

PDP/PackagePDP/Package

PDP/Package - BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRAVEL

BASIX

1/5 FL OZ (6mL) PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000992Afrin 0.05 % Nasal SprayPSN6
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN6
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD6
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD6
1000992Afrin 0.05 % Nasal SpraySY6
1000992Afrin 0.5 MG/ML Nasal SpraySY6
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY6

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
66715-5880-0Afrin Original6 mL in 1 BOTTLE, SPRAYSPRAY66
66715-5880-0Afrin Original1 in 1 BLISTER PACKSPRAY16
66715-7016-3Afrin Original1 in 1 BLISTER PACKSPRAY16
66715-7016-3Afrin Original6 mL in 1 BOTTLE, SPRAYSPRAY66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5880AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC.]6Current NDC, 2 package rows20241220_8a97c012-6a47-4607-9389-58a4eed17b08.zip
66715-7016AFRIN ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC.]6Current NDC, Legacy NDC, 2 package rows20241220_8a97c012-6a47-4607-9389-58a4eed17b08.zip

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
66715-701666715-7016-3
66715-588066715-5880-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
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
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDELil' Drug Store Products, Inc.8a97c012-6a47-4607-9389-58a4eed17b082024-12-18WarningsExact identifier
ndc (package): 66715-5880-0
ndc (package): 66715-7016-3
ndc (product): 66715-5880
ndc (product): 66715-7016
ndc11 (package): 66715701603
ndc11 (package): 66715588000
spl id: 298cebeb-00c0-c2e6-e063-6394a90a091c
spl set id: 8a97c012-6a47-4607-9389-58a4eed17b08

Reported adverse events (FAERS/openFDA)#

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