Sinufrin Decongestant

Manufacturer
NeilMed Pharmaceuticals Inc
Effective date
2026-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:50

Label at a glance#

ProductSinufrin Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure15 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 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor n To use: To spray, squeeze bottle quickly and firmly. Keep head upright and do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Oxymetazoline hydrochloride 0.05%

Purpose- Nasal Decongestant

Drug FactsDrug Facts

Uses

OTC - PURPOSE 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

UsesUses

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • Heart disease n High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland

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 product by more than one person may spread infection

Stop use and ask a doctor if symptoms persist
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WarningsWarnings

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

Ask Doctor Before UseAsk Doctor Before Use

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist

Stop UseStop Use

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 product by more than one person may spread infection

When Using SectionWhen Using Section

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

If pregnant or breast-feedingIf pregnant or breast-feeding

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

Keep out of reach of children.Keep out of reach of children.

Directions for Dosing

INSTRUCTIONS FOR USE SECTION

Adults and children 6 to 12 years of age (with adult supervision):
Per dose, 2 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:
consult a doctor n To use: To spray, squeeze bottle quickly and firmly. Keep head
upright and do not tilt head backward while spraying. Wipe nozzle clean after use.
Secure cap after use.

DirectionsDirections

Other Information

OTHER SAFETY INFORMATION

Store between 68° F (20° C) and 86° F (30° C)
Retain carton for future reference on full labeling

Other InformationOther Information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water

Inactive IngredientsInactive Ingredients

Uses

INDICATIONS & USAGE SECTION

Adults and children 6 to 12 years of age (with adult supervision)

Temporarily relieves nasal congestion due to:
Common cold n Hay fever Upper respiratory allergies Temporarily relieves sinus congestion and pressure
Shrinks swollen nasal membranes so you can breathe more freely

Indications and UsageIndications and Usage

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Oxymetazoline hydrochloride 0.05%

Each full spray releases 0.1 mL of solution

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.

DosageDosage

Do Not Use

OTC - DO NOT USE 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.

Do not UseDo not Use

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging label principal display panelsPackaging label principal display panels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1
1313914Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal SprayPSN1
1313914oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]SBD1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1
1313914Sinufrin Plus 0.05 % Nasal SpraySY1
1313914Sinufrin Plus 0.5 MG/ML Nasal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-355-01Sinufrin Decongestant1 in 1 CARTONSOLUTION11
13709-355-01Sinufrin Decongestant15 mL in 1 BOTTLESOLUTION151

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-35513709-355-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
Sinufrin DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc52a2e5f9-e0a2-02f7-e063-6294a90a3ae92026-05-25WarningsExact identifier
ndc (package): 13709-355-01
ndc (product): 13709-355
ndc11 (package): 13709035501
spl id: 52a2e5f9-e0a3-02f7-e063-6294a90a3ae9
spl set id: 52a2e5f9-e0a2-02f7-e063-6294a90a3ae9

Reported adverse events (FAERS/openFDA)#

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