FDA.reportPublic FDA data

Children Afrin Extra Moisturizing Stuffy Nose Pump Mist

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:20:08

Label at a glance#

ProductChildren Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist
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

children 2 to under 6 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. children under 2 years of age: consult a doctor To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by de...

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 0.025%

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 or a child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

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

Stop use and ask a doctor if symptoms persist


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • children 2 to under 6 years of age (with adult supervision): 2 or

3 sprays in each nostril not more often than every 10 to 12
hours. Use only recommended amount. Do not exceed 2
doses in any 24-hour period.

  • children under 2 years of age: consult a doctor

To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly up to 10 times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke. 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 carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-317-2165

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton kids 6 under artworkCarton kids 6 under artwork

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Children's Afrin ®

No Drip EXtra Moisturizing Stuffy Nose Pump Mist

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606551Afrin 0.025 % Nasal SprayPSN9
2606550oxymetazoline hydrochloride 0.025 % Nasal SprayPSN9
2606551oxymetazoline hydrochloride 0.25 MG/ML Nasal Spray [Afrin]SBD9
2606550oxymetazoline hydrochloride 0.25 MG/ML Nasal SpraySCD9
2606551Afrin 0.025 % Nasal SpraySY9
2606551Afrin 0.25 MG/ML Nasal SpraySY9
2606550oxymetazoline hydrochloride 0.025 % Nasal SpraySY9

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
11523-0091-1Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED159
11523-0091-1Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist1 in 1 CARTONSPRAY, METERED19
11523-0091-2Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist2 in 1 CARTONSPRAY, METERED29
11523-0091-2Children Afrin Extra Moisturizing Stuffy Nose Pump MistStuffy Nose Pump Mist15 mL in 1 BOTTLE, PUMPSPRAY, METERED159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0091-1ML - Milliliter11523-0091eb72e68d-8726-4f9d-bb27-a955e44153b012025-06-13

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-009111523-0091-1, 11523-0091-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.e3b239bd-ffc7-600c-e053-2a95a90a3b3b2025-12-04WarningsExact identifier
ndc (package): 11523-0091-1
ndc (package): 11523-0091-2
ndc (product): 11523-0091
ndc11 (package): 11523009101
ndc11 (package): 11523009102
spl id: 4526d3b2-bf61-2bf3-e063-6394a90a4fad
spl set id: e3b239bd-ffc7-600c-e053-2a95a90a3b3b

Reported adverse events (FAERS/openFDA)#

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