FDA.reportPublic FDA data

Afrin No Drip Night

Manufacturer
Bayer HealthCare LLC.
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:41:01

Label at a glance#

ProductAfrin No Drip Night Chamomile
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies shrinks swollen nasal membranes so you can breathe more freely temporarily relieves sinus congestion and pressure

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Oxymetazoline hydrochloride 0.05%Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves nasal congestion due to:
    • common cold
  • hay fever
  • upper respiratory allergies
  • shrinks swollen nasal membranes so you can breathe more

freely

  • temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

•heart disease • high blood pressure

•thyroid disease • diabetes

•trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

Directions

  • 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: 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 several 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 and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Other information

OTHER SAFETY INFORMATION

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • retain carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments? 1-800-317-2165

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11523-116011523-1160NEW

Oxymetazoline HCl

Nasal Solution-Nasal Decongestant

Afrin®

NoDrip

Won't drip from nose or down throat

Night

with soothing chamomile scent

PUMP MIST

Instant

Congstion

Relief for a

More Restful

Night

Up to 12

HOUR

RELIEF

Colds · Allergies

#1 Doctor Recommended

Nasal Decongestant Spray

1/2 FL OZ (15 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000992Afrin 0.05 % Nasal SprayPSN7
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN7
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD7
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD7
1000992Afrin 0.05 % Nasal SpraySY7
1000992Afrin 0.5 MG/ML Nasal SpraySY7
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY7

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
11523-1160-12026-01-29C16284748780-149896155-c7e1-586f-e063-e6dba90add90Afrin No Drip Night Pump Mist UI 1612461
11523-1160-22026-01-29C16284748780-149896155-c7e1-586f-e063-e6dba90add90Afrin No Drip Night Pump Mist UI 1612461

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1160-1Afrin No Drip NightChamomile0.5 mL in 1 BOTTLE, PUMPSPRAY, METERED0.57
11523-1160-2Afrin No Drip NightChamomile15 mL in 1 BOTTLE, PUMPSPRAY, METERED157
11523-1160-2Afrin No Drip NightChamomile1 in 1 CARTONSPRAY, METERED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1160AFRIN NO DRIP NIGHT CHAMOMILE (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]7Legacy NDC, 3 package rows20241208_a3f997c2-d6b5-d9d5-e053-2995a90a6f26.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-116011523-1160-1, 11523-1160-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
POVIDONEFZ989GH94EIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT

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
289df0b4-39de-58d8-e063-6394a90ab02fa3f997c2-d6b5-d9d5-e053-2995a90a6f262024-12-06WarningsExact identifier
spl id: 289df0b4-39de-58d8-e063-6394a90ab02f
spl set id: a3f997c2-d6b5-d9d5-e053-2995a90a6f26

Reported adverse events (FAERS/openFDA)#

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