FDA.reportPublic FDA data

7 Select Nasal Spray Original 1 oz (58849) 2019

Manufacturer
7-ELEVEN, INC.
Effective date
2019-11-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:01:31

Label at a glance#

Product7 Select Original Nasal
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Other information store beween 20° to 25°C (68° to 77°F) retain carton for future reference on full labeling

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                          Purpose

Oxymetazoline HCl 0.05%...........................Nasal decongestant

OTC - PURPOSE SECTION

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 childrean. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doeses in any 24-hour period.
  • children under 6 years of age: ask a doctor. Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5884958849

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
10202-849-302022-01-28C16284748780-1d6a99b39-6af9-a426-e053-dadaa90af4c27 Select Nasal Spray Original 1 oz (58849) 2019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10202-849-307 Select Original Nasal1 in 1 BOXSPRAY17
10202-849-307 Select Original Nasal30 mL in 1 BOTTLE, SPRAYSPRAY307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10202-8497 SELECT ORIGINAL NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [7-ELEVEN, INC.]7Legacy NDC, 2 package rows20191115_5b821b46-3a16-43da-8a23-fa3f03638f42.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10202-84910202-849-30

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
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
POVIDONE K30U725QWY32XIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
BENZODODECINIUM CHLORIDEY5A751G47HIACT

Source Document#

Source XML

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
9753f558-fdde-b2bc-e053-2995a90a37175b821b46-3a16-43da-8a23-fa3f03638f422019-11-14WarningsExact identifier
spl id: 9753f558-fdde-b2bc-e053-2995a90a3717
spl set id: 5b821b46-3a16-43da-8a23-fa3f03638f42

Reported adverse events (FAERS/openFDA)#

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