Afrin

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:20:21

Label at a glance#

ProductAfrin Severe Congestion

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

Contacts and useful links#

PhoneLabel contact1-800-317-2165

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
thyroid disease
diabetes
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, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? 1-800-317-2165

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11523-7020Afrin^®

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Severe Congestion

NASAL SPRAY

Fast, Powerful
Congestion
Relief

Colds • Allergies

up to 12
Hour
Relief

Maximum
Strength
plus Menthol

#1 Doctor & Pharmacist
Recommended Nasal Brand

BAYER

1/2 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1000992	Afrin 0.05 % Nasal Spray	PSN	9
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	9
1000992	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]	SBD	9
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	9
1000992	Afrin 0.05 % Nasal Spray	SY	9
1000992	Afrin 0.5 MG/ML Nasal Spray	SY	9
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OXYMETAZOLINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-7020-1	AfrinSevere Congestion	1 in 1 CARTON	SPRAY	1		9
11523-7020-1	AfrinSevere Congestion	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7020-1	ML - Milliliter	11523-7020	fc3de170-d4de-45f4-a4cf-0d8f24558ee0	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Oxymetazoline hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	1
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
camphor (synthetic)	INACTIVE INGREDIENT	5TJD82A1ET	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
eucalyptol	INACTIVE INGREDIENT	RV6J6604TK	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	1
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Afrin Severe Congestion
Oxymetazoline hydrochloride
BENZALKONIUM CHLORIDE
BENZYL ALCOHOL
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
EUCALYPTOL
MENTHOL
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC
OXYMETAZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-7020	11523-7020-1

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
EUCALYPTOL	RV6J6604TK	IACT
MENTHOL	L7T10EIP3A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
OXYMETAZOLINE HYDROCHLORIDE	K89MJ0S5VY	ACTIB

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 2 · 70 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
eucalyptol	EUCALYPTOL	RV6J6604TK	JELLY / NASAL	68.5 mg		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii+route 6 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii+route 6 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii+route 6 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SOLUTION / ORAL	40 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / NASAL	0.2 mg/1ml		Exact identifier — unii+route 6 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	2.98 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / NASAL	0.2 mg/1ml		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAVENOUS	200 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	TABLET, EXTENDED RELEASE / ORAL		143 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRADERMAL	0.2 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	2.98 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAVENOUS	200 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SUSPENSION / OPHTHALMIC	0.43 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	0.22 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / SUBCUTANEOUS		14 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRADERMAL	0.2 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	TABLET, EXTENDED RELEASE / ORAL		143 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
camphor (synthetic)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	JELLY / NASAL	65 mg		Exact identifier — unii+route 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SOLUTION / ORAL	40 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	SOLUTION / NASAL	0.2 mg/1ml		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	0.22 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
eucalyptol	EUCALYPTOL	RV6J6604TK	DROPS / NASAL	0.2 mg/1ml		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii+route 6 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium phosphate, dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
camphor (synthetic)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	JELLY / NASAL	65 mg		Exact identifier — unii+route 2 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Afrin Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	a49a506e-aca2-4af0-a50b-dca2c031e61d	2025-12-05	Warnings	Exact identifier ndc (package): 11523-7020-1 ndc (product): 11523-7020 ndc11 (package): 11523702001 spl id: 453715d8-b7e1-c347-e063-6294a90a75c8 spl set id: a49a506e-aca2-4af0-a50b-dca2c031e61d

Reported adverse events (FAERS/openFDA)#

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