Oxymetazoline Hydrochloride Nasal Decongestant 12-Hour Spray

Manufacturer: Sun Pharmaceutical Industries, Inc. | Applied Laboratories, Inc.
Effective date: 2026-07-16
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: daily-update
Hydrated at: 2026-07-18 05:11:26

Label at a glance#

ProductOxymetazoline Hydrochloride 12-Hour

Active ingredientOXYMETAZOLINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporary relief of nasal congestion due to the common cold due to hay fever or other upper respiratory allergies associated with sinusitis reduces swelling of nasal passages temporarily restores freer breathing through the nose

Dosage and administration

Adults and children 6 to under 12 years of age (with supervision): 2 to 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 spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Contacts and useful links#

PhoneLabel contact1-866-923-4914

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

temporary relief of nasal congestion
- due to the common cold
- due to hay fever or other upper respiratory allergies
- associated with sinusitis
reduces swelling of nasal passages
temporarily restores freer breathing through the nose

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.

Do not use

OTC - DO NOT USE SECTION

for more than 3 days

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

When using this product

OTC - WHEN USING SECTION

frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Adults and children 6 to under 12 years of age (with supervision): 2 to 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 spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the
active ingredient
in Afrin ^®*

Nasal
Decongestant
12- Hour Spray

Oxymetazoline
Hydrochloride 0.05%

Maximum Strength

Fast Acting
Up To 12 Hours Relief

Contains the Active Ingredient
Recommended Most by
Physicians and Pharmacists

1 fl oz (30 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2030-3	ML - Milliliter	51672-2030	6438d50f-2bf2-4061-a793-5d3f37fb4b61	1	2012-07-24
51672-2030-5	ML - Milliliter	51672-2030	50c5526b-5725-4806-b309-7c4fdb3242e8	1	2012-07-24

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
polyethylene glycol 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
sodium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
sodium phosphate, monobasic, monohydrate	INACTIVE INGREDIENT	593YOG76RN	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Oxymetazoline Hydrochloride 12-Hour
Oxymetazoline Hydrochloride
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
EDETATE DISODIUM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
POLYETHYLENE GLYCOL 1450
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
OXYMETAZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-2030	51672-2030-5, 51672-2030-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
OXYMETAZOLINE HYDROCHLORIDE	K89MJ0S5VY	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2025-03-13	full-release	2026-06-01 00:57:11

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 4 · 234 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
povidone	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRAMUSCULAR		120 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SYRUP / ORAL	20.6 mg/5ml		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / TOPICAL	0.46 %w/v		Exact identifier — unii candidate 108 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1.84 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SYRUP / ORAL	20.6 mg/5ml		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRAMUSCULAR		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRA-ARTICULAR		14 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SOLUTION / INTRAVENOUS		27 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	15.55 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	OINTMENT / TOPICAL		921 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET / ORAL	31.72 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SYRUP / ORAL	20.6 mg/5ml		Exact identifier — unii candidate 108 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	SUPPOSITORY / URETHRAL	9.75 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	TABLET, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, DELAYED RELEASE / ORAL	35 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / INTRAVESICAL	0.12 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRAMUSCULAR		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	15.55 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION/ DROPS / OPHTHALMIC		8 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / SOFT TISSUE		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	LOTION / TOPICAL		8 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CREAM / TOPICAL		38 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	LOTION, AUGMENTED / TOPICAL		14 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	CAPSULE, EXTENDED RELEASE / ORAL		91 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / INTRAMUSCULAR		120 mg	Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CAPSULE / ORAL	600 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / TOPICAL	0.46 %w/v		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	CAPSULE, EXTENDED RELEASE / ORAL		91 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRAVITREAL	0.04 %w/v		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION / ORAL	10.06 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 90 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	SOLUTION / ORAL		6108 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CAPSULE / ORAL	600 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
sodium phosphate, monobasic, monohydrate	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	15.55 mg		Exact identifier — unii candidate 108 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	TABLET / ORAL	0.6 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
polyethylene glycol 1450	POLYETHYLENE GLYCOL 1450	OJ4Z5Z32L4	TABLET, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 90 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	CAPSULE, COATED PELLETS / ORAL	10.03 mg		Exact identifier — unii candidate 90 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
Oxymetazoline Hydrochloride 12-Hour	OXYMETAZOLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	34a79f8b-32b7-48db-a895-c942cc795292	2026-07-16	Warnings	Exact identifier ndc (package): 51672-2030-3 ndc (package): 51672-2030-5 ndc (product): 51672-2030 ndc11 (package): 51672203003 ndc11 (package): 51672203005 spl id: 56bb5577-e3d4-ae0b-e063-6394a90ab52c spl set id: 34a79f8b-32b7-48db-a895-c942cc795292

Reported adverse events (FAERS/openFDA)#

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