FDA.reportPublic FDA data

n-Drops NASAL DECONGESTANT

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:02

Label at a glance#

Productn-Drops NASAL DECONGESTANT
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 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 - 12 years (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

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline Hydrochloride - 0.05%

PURPOSE

OTC - PURPOSE SECTION

Nasal 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

Ask doctor before use 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 - 12 years (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

Sorbitol, Hydroxy propyl methyl cellulose, Sodium Chloride, Benzalkonium Chloride, Edetate Disodium, Sodium hydroxide, Water for injection.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST.

SPL UNCLASSIFIED SECTION

• Won't drip from nose or down throat

• Helps relieve congestion

Manufactured by:

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nasal10-1Nasal10-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-010-152023-02-08C16284748780-1f386c649-cdef-0266-e053-dadaa90a7c1an-Drops NASAL DECONGESTANT SPRAY
73921-010-152023-01-30C16284748780-1f386c649-cdef-0266-e053-dadaa90a7c1an-Drops NASAL DECONGESTANT SPRAY

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
73921-01073921-010-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
SORBITOL506T60A25RIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
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
f42b6ac8-c312-1273-e053-2995a90a0ddbf96dc26e-67bd-4c70-bb8a-5b66b96b2af52023-02-08WarningsExact identifier
spl set id: f96dc26e-67bd-4c70-bb8a-5b66b96b2af5

Reported adverse events (FAERS/openFDA)#

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