FDA.reportPublic FDA data

Nasal Spray

Manufacturer
Chain Drug Consortium | Product Quest Mfg
Effective date
2015-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:43:50

Label at a glance#

ProductNo Drip 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, Cellulose Gum, Disodium EDTA, Disodium Phosphate, Flavor, Microcrystalline Cellulose, PEG-12, Povidone, Sodium Phosphate, 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 MSD Consumer Care, INC., distributor of Afrin No Drip.

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 No Drip Original

Premier Value

Nasal Decongestant

No Drip

Nasal Spray

Oxymetazoline HCl Nasal Solution

12 HOUR PUMP MIST

Fast, Powerful Congestion Relief

  • Colds 
  • Allergies

Maximum Strength

1 FL OZ (30 mL)

image descriptionimage description

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-308-032020-01-31C16284748780-19d75b9d0-7ae9-f424-e053-dadaa90a57ceNasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-308-03No DripPremier Value1 in 1 CARTONSPRAY12
68016-308-03No DripPremier Value30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-308NO DRIP PREMIER VALUE (OXYMETAZOLINE HCL NASAL SOLUTION) SPRAY [CHAIN DRUG CONSORTIUM]2Legacy NDC, 2 package rows20151014_4e1f4180-5cf8-48a0-a01f-77cd4574e2a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-308-03ML - Milliliter68016-308bf28afaa-8fb7-4fa5-9811-d966ad919e3512022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VY2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZY2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3112
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N92
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY372
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-30868016-308-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
POVIDONEFZ989GH94EIACT
SODIUM PHOSPHATESE337SVY37IACT
WATER059QF0KO0RIACT

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 · 334 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAVENOUS400 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 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 DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYRUP / ORAL26.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FILM COATED / ORAL0.01 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37CREAM / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRAVENOUS10.6 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRASYNOVIAL0.1 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
44 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 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
55158443-c286-4ab5-ab0a-147ab9d683854e1f4180-5cf8-48a0-a01f-77cd4574e2a92015-10-14WarningsExact identifier
spl id: 55158443-c286-4ab5-ab0a-147ab9d68385
spl set id: 4e1f4180-5cf8-48a0-a01f-77cd4574e2a9

Reported adverse events (FAERS/openFDA)#

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