OXYMETAZOLINE HYDROCHLORIDE

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:27:50

Label at a glance#

ProductOXYMETAZOLINE HYDROCHLORIDE
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure8 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

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.

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 for more than 3 days.

Ask a doctor before use if you have:

° heart disease ° high blood pressure

° thyroid disease ° diabetes

° difficulty in urination due to enlargement of the prostate gland

When using this product, frequent or prolonged use may cause nasal congestion to recur or worsen.

Stop use and ask a doctor if symptoms persist.

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

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? Cal 1-866-923-4914

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nasal Spray 0.05%Nasal Spray 0.05%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-875-152019-09-24C16284748780-1934fe258-4c20-48b1-e053-8cdaa90a720aNasal Decongestant Drug Facts
21695-875-302019-09-24C16284748780-1934fe258-4c20-48b1-e053-8cdaa90a720aNasal Decongestant Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-875-15OXYMETAZOLINE HYDROCHLORIDE15 mL in 1 BOTTLE, SPRAYSPRAY, METERED152
21695-875-30OXYMETAZOLINE HYDROCHLORIDE30 mL in 1 BOTTLE, SPRAYSPRAY, METERED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-875OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20110422_dd196e5a-a791-47ad-aab5-3f2e760f758a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-875-15ML - Milliliter21695-87531326608-4334-4e90-a120-117afe46d69812012-07-24
21695-875-30ML - Milliliter21695-875ca78f605-b338-4687-943e-8d828613114212012-07-24
51672-2030-3ML - Milliliter51672-20306438d50f-2bf2-4061-a793-5d3f37fb4b6112012-07-24
51672-2030-5ML - Milliliter51672-203050c5526b-5725-4806-b309-7c4fdb3242e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VY2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZY2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L42
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RN2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
21695-87521695-875-15, 21695-875-30
51672-2030

Ingredients#

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

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

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 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNLOTION / TOPICAL8 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / TOPICAL0.46 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUPPOSITORY / URETHRAL9.75 mgExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSYRUP / ORAL20.6 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRALESIONAL14 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVENOUS120 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRAMUSCULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / INTRAVESICAL0.12 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET / ORAL0.6 mgExact identifier — unii candidate
8 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNLOTION, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / OPHTHALMIC0.04 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4OINTMENT / TOPICAL921 mgExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / SOFT TISSUE13 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET / ORAL31.72 mgExact identifier — unii candidate
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAMUSCULAR120 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / ORAL10.06 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / SUBLINGUAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNCREAM / TOPICAL10 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, FILM COATED / ORAL0.11 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRAVITREAL0.04 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRA-ARTICULAR14 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNCAPSULE / ORAL600 mgExact identifier — unii candidate
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
8 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SOLUTION / ORAL6108 mgExact identifier — unii candidate
8 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4SUSPENSION / ORAL4000 mgExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SOLUTION / INTRAVENOUS27 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 1450POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4TABLET, FILM COATED / ORAL0.13 mgExact identifier — unii candidate
8 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.61 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRASYNOVIAL13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRA-ARTICULAR13 mgExact identifier — unii candidate
36 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymetazoline Hydrochloride 12-HourOXYMETAZOLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.34a79f8b-32b7-48db-a895-c942cc7952922026-07-16WarningsExact identifier
ndc (product): 51672-2030
d0da5393-8c1d-48ce-85e6-22213f6a4ba2dd196e5a-a791-47ad-aab5-3f2e760f758a2011-02-21WarningsExact identifier
spl id: d0da5393-8c1d-48ce-85e6-22213f6a4ba2
spl set id: dd196e5a-a791-47ad-aab5-3f2e760f758a

Reported adverse events (FAERS/openFDA)#

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