Breaze Nasal

Manufacturer: Samson Pharmaceuticals, Inc.
Effective date: 2022-11-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:55:39

Label at a glance#

ProductBreaze Nasal Sinus Colds and Allergies

Active ingredientOxymetazoline hydrochloride

Label structure11 sections

Indications and uses

♦ Temporarily relieves nasal congestion due to: ♦ Common cold. Hay fever. Sinusitis ♦ Upper respiratory allergies ♦ Shrinks swollen nasal membranes so you can breathe more freely

Dosage and administration

Adult & children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in age nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 –hr 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 20C to 25C (68 to 77F). ♦ Retain carton for future reference on full labeling.

Contacts and useful links#

PhoneLabel contact1-888-995-9935

Websitewww.samson.pharmaceutical.com

www.samson.pharmaceutical.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACT

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. Sinusitis
- Upper respiratory allergies
- Shrinks swollen nasal membranes so you can breathe more freely

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

High blood pressure
Heart disease
Diabetes
Thyroid diseases
Trouble urinating due to enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

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.
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

Adult & children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in age nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 –hr 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 20C to 25C (68 to 77F).
Retain carton for future reference on full labeling.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Eucalyptus Globulus (Eucaplyptus) Leaf Oil, Camphor, Menthol, Editate Disodium, Sodium Phosphate Dibasic, Polysorbate 80, Sodium Phosphate Monobasic, Propylene Glycol, Water (Aqua).

Question or Comments?

OTC - QUESTIONS SECTION

1-888-995-9935

SPL UNCLASSIFIED SECTION

Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA

Visit our website at
www.samson.pharmaceutical.com
Made in USA

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Breaze^®

MADE IN THE U.S.A.
WITH PRIDE

Relieves Congestion

Nasal
Spray

Sinus
Colds & Allergies

12 Hour Relief

Oxymetazoline HCl
Nasal Solution
Nasal Decongestant

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	2
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	2
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	2

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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
20146-4006-1	2025-01-30	C162847	48780-1	9d75b9d0-9ef2-f424-e053-dadaa90a57ce	Breaze ® Nasal Sinus Colds and Allergies
20146-4006-1	2023-07-17	C162847	48780-1	9d75b9d0-9ef2-f424-e053-dadaa90a57ce	Breaze ® Nasal Sinus Colds and Allergies
20146-4006-1	2020-01-31	C162847	48780-1	9d75b9d0-9ef2-f424-e053-dadaa90a57ce	Breaze ® Nasal Sinus Colds and Allergies

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
20146-4006-1	Breaze Nasal Sinus Colds and Allergies	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2
20146-4006-1	Breaze Nasal Sinus Colds and Allergies	1 in 1 CARTON	SPRAY	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
20146-4006	BREAZE NASAL SINUS COLDS AND ALLERGIES (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.]	2	Legacy NDC, 2 package rows	20230718_b1c948a9-dc6c-4cf4-88e0-105d564f6712.zip

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
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Eucalyptus Oil	INACTIVE INGREDIENT	2R04ONI662	1
Menthol, Unspecified Form	INACTIVE INGREDIENT	L7T10EIP3A	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sodium Phosphate, Monobasic, Anhydrous	INACTIVE INGREDIENT	KH7I04HPUU	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Breaze Nasal Sinus Colds and Allergies
Oxymetazoline hydrochloride
Oxymetazoline
Benzalkonium Chloride
Eucalyptus Oil
Menthol, Unspecified Form
Edetate Disodium
Sodium Phosphate, Dibasic, Anhydrous
Polysorbate 80
Sodium Phosphate, Monobasic, Anhydrous
Propylene Glycol
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
20146-4006	20146-4006-1

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
Name	UNII	Kind
Oxymetazoline hydrochloride	K89MJ0S5VY	ACTIB
Benzalkonium Chloride	F5UM2KM3W7	IACT
Eucalyptus Oil	2R04ONI662	IACT
Menthol, Unspecified Form	L7T10EIP3A	IACT
Edetate Disodium	7FLD91C86K	IACT
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
Polysorbate 80	6OZP39ZG8H	IACT
Sodium Phosphate, Monobasic, Anhydrous	KH7I04HPUU	IACT
Propylene Glycol	6DC9Q167V3	IACT
Water	059QF0KO0R	IACT

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 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRA-ARTICULAR		13 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	18.81 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Menthol, Unspecified Form	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION / INTRAVENOUS	40 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Menthol, Unspecified Form	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	SOLUTION/ DROPS / OPHTHALMIC	0.46 %w/v		Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION / INTRAVENOUS	12.8 mg		Exact identifier — unii candidate 41 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / ORAL		66 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRALESIONAL		28 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FILM COATED / ORAL	0.01 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	INJECTION, SUSPENSION / INTRALESIONAL		10 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	CREAM / VAGINAL	ADJ PH		Exact identifier — unii candidate 41 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sodium Phosphate, Monobasic, Anhydrous	SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	KH7I04HPUU	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 41 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 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
0df89447-0374-443c-b1ec-ab0193380a4b			b1c948a9-dc6c-4cf4-88e0-105d564f6712	2022-11-29	Warnings	Exact identifier spl id: 0df89447-0374-443c-b1ec-ab0193380a4b spl set id: b1c948a9-dc6c-4cf4-88e0-105d564f6712

Reported adverse events (FAERS/openFDA)#

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