Indications and 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
oxymetazoline hydrochloride
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2025-06-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:46
Label at a glance#
Productoxymetazoline hydrochloride
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure9 sections
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: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure ...
Storage and handling
store at 20-25°C (68-77°F) retain carton for future reference on full labeling
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal decongestant
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
Ask a doctor before use if you have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
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
Stop use and ask a doctor if
symptoms persist
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- 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: ask a doctor
To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.
Other information
- store at 20-25°C (68-77°F)
- retain carton for future reference on full labeling
Inactive ingredients
benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
Questions or comments?
1-800-719-9260
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| OXYMETAZOLINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e67be450-f8e4-4bc1-88bd-1259d379f55f | Product name | 1 | 20210127 |
| c53f3286-4062-4cf5-8355-399519c639a6 | Product name | 1 | 20170424 |
| a993dfc5-f219-4460-bde6-30dd724d9ef0 | Product name | 1 | 20160818 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3422-1 | 2025-03-04 | C162847 | 48780-1 | 2cef2736-8f70-d83d-e063-dadaa90ab31f | Perrigo Oxymetazoline HCl 0.05% Drug Facts |
| 68071-3422-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f70-d83d-e063-dadaa90ab31f | Perrigo Oxymetazoline HCl 0.05% Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3422-1 | oxymetazoline hydrochloride | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 3 | |
| 68071-3422-1 | oxymetazoline hydrochloride | 1 in 1 CARTON | SPRAY | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-410-59 | ML - Milliliter | 45802-410 | 54e747ad-1a30-4db2-8182-ca670b35ec25 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- oxymetazoline hydrochloride
- BENZALKONIUM CHLORIDE
- BENZYL ALCOHOL
- SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
- EDETATE DISODIUM
- SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- OXYMETAZOLINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-3422 | 68071-3422-1 |
| 45802-410 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fd058e2b-5445-e416-e053-6394a90a611b | 2025-06-03 | Warnings | 68071-3422-1 68071-3422 68071342201 36b1caf3-8f0e-088c-e063-6394a90a6a07 fd058e2b-5445-e416-e053-6394a90a611b |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | a1103cd8-344b-4a65-8a60-3c7be86d01a6 | 2024-09-11 | Warnings | 45802-410 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.