SinuFrin

Manufacturer: NeilMed Pharmaceuticals Inc
Effective date: 2024-01-11
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:07:06

Label at a glance#

ProductSinuFrin NeilMed

Active ingredientOXYMETAZOLINE HYDROCHLORIDE

Label structure15 sections

Indications and uses

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

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.

Storage and handling

Store between 20 to 40 °C (68 to 104 °F) Retain carton for future reference on full labeling

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

0.05% Oxymetazoline Hydrochloride

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

Warnings

WARNINGS SECTION

Do not exceed recommended dosage. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Warnings

OTC - ASK DOCTOR SECTION

Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.

Directions for Dosing

DOSAGE & ADMINISTRATION SECTION

Other Information

STORAGE AND HANDLING SECTION

Store between 20 to 40 °C (68 to 104 °F)
Retain carton for future reference on full labeling

Warnings

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.

Warnings

OTC - DO NOT USE SECTION

Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may
cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high
blood pressure, thyroid disease or diabetes unless directed by a doctor. Adult males with prostate disease, do not use this product.

Other Information

OTC - WHEN USING SECTION

Keep head in an upright position for use. Do not tilt head backward while spraying. Wipe nozzle clean after each use.

Warnings

OTC - STOP USE SECTION

Stop using this product for more than 3 consecutive days. Stop and ask your doctor if symptoms of nasal congestion persist after using 3 consecutive days.

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Uses

OTC - PURPOSE SECTION

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SinuFrin bottle label

Box label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	7
1313914	Sinufrin Plus 12 Hour Decongestant 0.05 % Nasal Spray	PSN	7
1313914	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sinufrin Plus]	SBD	7
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	7
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	7
1313914	Sinufrin Plus 0.05 % Nasal Spray	SY	7
1313914	Sinufrin Plus 0.5 MG/ML Nasal Spray	SY	7

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13709-231-04	2020-04-18	C162847	48780-1	9d75b9d1-0369-f424-e053-dadaa90a57ce	Drug Facts
13709-231-07	2020-04-18	C162847	48780-1	9d75b9d1-0369-f424-e053-dadaa90a57ce	Drug Facts
13709-231-04	2020-01-31	C162847	48780-1	9d75b9d1-0369-f424-e053-dadaa90a57ce	Drug Facts
13709-231-07	2020-01-31	C162847	48780-1	9d75b9d1-0369-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13709-231-04	SinuFrinNeilMed	15 mL in 1 BOX	SPRAY	15	7
13709-231-07	SinuFrinNeilMed	15 mL in 1 BOTTLE	SPRAY	15	7
13709-231-12	SinuFrinNeilMed	30 mL in 1 BOTTLE	SPRAY	30	7
13709-231-12	SinuFrinNeilMed	1 in 1 CARTON	SPRAY	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13709-231	SINUFRIN NEILMED (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [NEILMED PHARMACEUTICALS INC]	7	Current NDC, Legacy NDC, 4 package rows	20240112_f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	3
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

SinuFrin NeilMed
Oxymetazoline Hydrochloride
SODIUM CHLORIDE
SODIUM BICARBONATE
PROPYLENE GLYCOL
EDETATE DISODIUM
BENZALKONIUM CHLORIDE
WATER
OXYMETAZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13709-231	13709-231-07, 13709-231-04, 13709-231-12

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT
OXYMETAZOLINE HYDROCHLORIDE	K89MJ0S5VY	ACTIB

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 3 · 152 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / BUCCAL		240 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE / ORAL		320 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / ORAL		360 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GRANULE, EFFERVESCENT / ORAL	267 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVENOUS	812 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, CHEWABLE / ORAL	140 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	POWDER, FOR SOLUTION / ORAL	1250 mg/100ml		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	POWDER, FOR SOLUTION / ORAL	1250 mg/100ml		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / SUBLINGUAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / BUCCAL		240 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	SOLUTION / RESPIRATORY (INHALATION)	2 %w/w		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		3219 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		3059 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAVITREAL	0.18 %w/v		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / SUBLINGUAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, FILM COATED / ORAL		86 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, CHEWABLE / ORAL	140 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRATHECAL	0.05 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / ORAL	1300 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING / ORAL		107 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / SUBLINGUAL		6 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INSERT / VAGINAL		129 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, COATED / ORAL	10.6 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 136 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION / INTRAMUSCULAR		175 mg	Exact identifier — unii candidate 136 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
SinuFrin NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	2024-01-11	Warnings	Exact identifier ndc (package): 13709-231-04 ndc (package): 13709-231-12 ndc (package): 13709-231-07 ndc (product): 13709-231 ndc11 (package): 13709023112 ndc11 (package): 13709023104 ndc11 (package): 13709023107 spl id: 0eb0d276-2eba-1c8d-e063-6294a90ae9ff spl set id: f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae

Reported adverse events (FAERS/openFDA)#

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