FDA.reportPublic FDA data

SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol

Manufacturer
Kenvue Brands LLC
Effective date
2025-05-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:08

Label at a glance#

ProductSUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol
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 Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly severa...

Storage and handling

store at 20-25°C (68-77°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 0.05%

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

Warnings

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

Stop use and ask a doctor if

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 (1-800-222-1222).

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 Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime 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

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • retain carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

How to use

INSTRUCTIONS FOR USE SECTION

Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-368-01

NEW

SUDAFED ®OM

Oxymetazoline HCl 0.05%,

Nasal Decongestant

NO DRIP

SINUS SEVERE

WITH COOLING MENTHOL

• MAXIMUM STRENGTH

• FAST SINUS CONGESTION & PRESSURE RELIEF

COLDS & ALLERGIES

UP TO

12HR

RELIEF

NASAL MIST

1 fl oz (30 mL)

sudafed-1sudafed-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN1
1001081Sudafed OM 0.05 % Nasal SprayPSN1
1001081oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]SBD1
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY1
1001081Sudafed OM 0.05 % Nasal SpraySY1
1001081Sudafed OM 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
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-368-01SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol1 in 1 CARTONSPRAY11
50580-368-01SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol30 mL in 1 BOTTLESPRAY301

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-36850580-368-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTOLRV6J6604TKIACT
MENTHOLL7T10EIP3AIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
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
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
ndc (package): 50580-368-01
ndc (product): 50580-368
ndc11 (package): 50580036801
spl id: 33fe2091-3984-713a-e063-6394a90ad28c
spl set id: 33fe0e49-3de5-8afd-e063-6294a90a0ad5

Reported adverse events (FAERS/openFDA)#

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