Nasal Spray

Manufacturer
Chain Drug Consortium | Product Quest Mfg
Effective date
2015-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:43:50

Label at a glance#

ProductNo Drip Severe Congestion Premier Value
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

Adults and children 6 to 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 within any 24-hour period. Children under 6 years of age: Ask a doctor. Shake well before use. Before using for the first time remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with...

Storage and handling

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

Label contents#

Full prescribing information#

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
  • Shrinks swollen nasal membranes so you can breathe more freely

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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

symptoms persist.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 to 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 within any 24-hour period.
  • Children under 6 years of age: Ask a doctor.

Shake well before use. Before using for the first time remove the protective cap from the tip and prime metered 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 each use.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Benzyl Alcohol, Camphor, Edetate Disodium, Eucalyptol, Menthol, Microcrystalline Cellulose, Carboxymethylcellulose Sodium, Polyethylene Glycol, Povidone, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water.

Additional information listed on other panels

SPL UNCLASSIFIED SECTION

SAFETY SEALED: DO NOT USE IF IMPRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks Sinex.

Distributed By:

Chain Drug Consortium

3301 NW Boca Raton Blvd, Suite 101

Boca Raton, FL 33431

Made in USA

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Afrin

Premier Value

Nasal Decongestant

No Drip

​SEVERE CONGESTION

​NASAL SPRAY ​

Oxymetazoline HCl Nasal Solution

12 HOUR PUMP MIST

Fast, Powerful Congestion Relief

  • Colds 
  • Allergies

Maximum

Strength

plus Menthol

1 FL OZ (30 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3

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
68016-309-032020-01-31C16284748780-19d75b9d1-29e2-f424-e053-dadaa90a57ceNasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-309-03No Drip Severe CongestionPremier Value1 in 1 CARTONSPRAY13
68016-309-03No Drip Severe CongestionPremier Value30 mL in 1 BOTTLE, SPRAYSPRAY303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-309NO DRIP SEVERE CONGESTION PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]3Legacy NDC, 2 package rows20151014_5ab118a9-6501-40db-b038-b8234d98ac61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-309-03ML - Milliliter68016-3094b3b1d0b-4e89-421f-b5cf-29d08bc35fe912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VY3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZY3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W73
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH3
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET3
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19X3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TK3
MENTHOLINACTIVE INGREDIENTL7T10EIP3A3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3
POVIDONEINACTIVE INGREDIENTFZ989GH94E3
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F3
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUU3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-30968016-309-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 6 · 339 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR18.81 mgExact identifier — unii candidate
41 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii candidate
48 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FOR SUSPENSION / ORAL60 mgExact identifier — unii candidate
48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / OPHTHALMIC1.21 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLOZENGE / TRANSMUCOSAL112 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FILM COATED / ORAL0.01 mgExact identifier — unii candidate
48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, EXTENDED RELEASE / ORAL210 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUINJECTION, SOLUTION / INTRAVENOUS0.62 %w/vExact identifier — unii candidate
41 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUSOLUTION / INTRAVESICAL0.12 mgExact identifier — unii candidate
41 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUSOLUTION/ DROPS / OPHTHALMIC0.46 %w/vExact identifier — unii candidate
41 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUINJECTION / INTRAVENOUS12.8 mgExact identifier — unii candidate
41 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKJELLY / NASAL68.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUINJECTION / SUBCUTANEOUS33.1 mgExact identifier — unii candidate
41 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
2 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9a036ed6-9da7-4249-984c-ca7f44c1bf1e5ab118a9-6501-40db-b038-b8234d98ac612015-10-14WarningsExact identifier
spl id: 9a036ed6-9da7-4249-984c-ca7f44c1bf1e
spl set id: 5ab118a9-6501-40db-b038-b8234d98ac61

Reported adverse events (FAERS/openFDA)#

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