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NDC 45802-0410-59 oxymetazoline hcl 0.05 g/100mL Details

oxymetazoline hcl 0.05 g/100mL

oxymetazoline hcl is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is OXYMETAZOLINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.

Related Packages: 45802-0410-59
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray

Product Information

NDC	45802-0410
Product ID	45802-410_2e17d138-f4a7-4f1a-b7f8-7ec77e591263
Associated GPIs	42102040102010
GCN Sequence Number	008039
GCN Sequence Number Description	oxymetazoline HCl SPRAY 0.05 % NASAL
HIC3	Q7D
HIC3 Description	NOSE PREPARATIONS, VASOCONSTRICTORS(OTC)
GCN	34062
HICL Sequence Number	003417
HICL Sequence Number Description	OXYMETAZOLINE HCL
Brand/Generic	Generic
Proprietary Name	oxymetazoline hcl
Proprietary Name Suffix	n/a
Non-Proprietary Name	oxymetazoline hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	0.05
Active Ingredient Units	g/100mL
Substance Name	OXYMETAZOLINE HYDROCHLORIDE
Labeler Name	Padagis Israel Pharmaceuticals Ltd
Pharmaceutical Class	Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45802-0410-59 (45802041059)

Pricing Information
NDC Package Code	45802-410-59
Billing NDC	45802041059
Package	1 BOTTLE, SPRAY in 1 CARTON (45802-410-59) / 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2005-12-05
NDC Exclude Flag	N
Price Per Unit	0.07251
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	NASAL SPRAY 0.05%
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL a1103cd8-344b-4a65-8a60-3c7be86d01a6 Details

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

Compare to Afrin® active ingredient

Oxymetazoline HCl 0.05%

Nasal Decongestant

Fast, Powerful Congestion Relief

For Colds & Allergies

Maximum Strength

12 Hour Relief

Spray Mist

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HCL

oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-410
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-410-59	1 in 1 CARTON	12/05/2005
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/05/2005

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: 2e17d138-f4a7-4f1a-b7f8-7ec77e591263

Set id: a1103cd8-344b-4a65-8a60-3c7be86d01a6

Version: 6

Effective Time: 20211108