FDA.reportPublic FDA data

Maximum Strenth Nasal

Manufacturer
Walgreens | Product Quest Mfg.
Effective date
2018-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:38

Label at a glance#

ProductMaximum Strenth Nasal
Active ingredientOxymetazoline Hydrochloride
Label structure6 sections

Indications and uses

For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

Dosage and administration

Adults and children 6 to under 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 in any 24-hour period. Children under 6 years of age : consult a doctor.

Label contents#

Full prescribing information#

Active ingredient                                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline Hydrochloride - 0.05%           Nazal Decongestant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies.

Warnings

WARNINGS SECTION

Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

When using this product

Do not exceed recommended dosage

Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 to under 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 in any 24-hour period. Children under 6 years of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride
Camphor
Disodium EDTA
Eucalyptol
Glycine
Menthol
Polysorbate 80
Propylene Glycol
Sodium Chloride
Sodium Hydroxide
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage 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
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-7003-012020-01-31C16284748780-19d75b9d0-687d-f424-e053-dadaa90a57ceWalgreens Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7003-01Maximum Strenth Nasal22 mL in 1 BOTTLELIQUID223
0363-7003-01Maximum Strenth Nasal1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7003MAXIMUM STRENTH NASAL (OXYMETAZOLINE HYDROCHLORIDE - 0.05%) LIQUID [WALGREENS]3Legacy NDC, 2 package rows20180220_5a5b301b-a224-41f5-8b62-c382c71e33e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7003-01ML - Milliliter0363-7003746fce7b-f719-47c2-92b5-a5d0e3740fb312022-06-06

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-70030363-7003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oxymetazoline HydrochlorideK89MJ0S5VYACTIB
Benzalkonium ChlorideF5UM2KM3W7IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
EDETATE DISODIUM7FLD91C86KIACT
EucalyptolRV6J6604TKIACT
GlycineTE7660XO1CIACT
MentholL7T10EIP3AIACT
Polysorbate 806OZP39ZG8HIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Chloride451W47IQ8XIACT
Sodium Hydroxide55X04QC32IIACT
water059QF0KO0RIACT

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
bc7ea4dd-280c-4d01-833e-1dacca8541a25a5b301b-a224-41f5-8b62-c382c71e33e82018-02-19WarningsExact identifier
spl id: bc7ea4dd-280c-4d01-833e-1dacca8541a2
spl set id: 5a5b301b-a224-41f5-8b62-c382c71e33e8

Reported adverse events (FAERS/openFDA)#

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