Naphazoline

Overview

Naphazoline is a rapid acting imidazoline sympathomimetic vasoconstrictor of ocular or nasal artierioles. It acts to decrease congestion and is found in many over the counter (OTC) eye drops and nasal preparations. Naphazoline was first developed in 1942 as a nasal formulation for congestion.

Indication

Naphazoline is indicated for use as OTC eyedrops for ocular vasoconstriction or as a nasal preparation for nasal congestion.

Associated Conditions

Allergic Conjunctivitis (AC)
Bacterial Conjunctivitis
Blepharoconjunctivitis
Conjunctivitis
Dacryocystitis
Dacryostenosis
Dermatitis, Eczematous of the Eyelid
Eye Pain
Eye redness
Foreign body sensation in eyes
Iritis
Lacrimation
Nasal Allergies
Nasal Congestion
Noninfective conjunctivitis
Otitis Media (OM)
Photophobia
Ocular bacterial infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Tolerability of PRO-185	2022/07/22	NCT05470868	Phase 1	Completed	Laboratorios Sophia S.A de C.V.
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors	2017/10/27	NCT03324113	Phase 1	Completed	Sanofi
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal	2012/02/15	NCT01533220	Phase 3	Completed	EMS
Comparison of Tolerability Between Two Allergy Drops	2011/07/11	NCT01390961	Phase 4	UNKNOWN	Hom, Milton M., OD, FAAO
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.	2008/10/09	NCT00770133	Phase 3	Completed	Bausch & Lomb Incorporated
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.	2008/10/09	NCT00769886	Phase 3	Completed	Bausch & Lomb Incorporated

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Exchange Select Maximum Redness Relief Eye Drops	Army and Air Force Exchange Service	55301-998	OPHTHALMIC	0.03 g in 100 mL	1/1/2024
Harris Teeter Redness Relief Eye Drops	Harris Teeter, LLC.	69256-979	OPHTHALMIC	0.012 g in 100 mL	1/1/2024
SERYNTH FAST RELIEF NASAL	Jiangxi Hemei Pharmaceutical Co., Ltd	84010-117	NASAL	0.05 g in 100 mL	5/23/2025
AK-Con	Rebel Distributors Corp.	21695-915	OPHTHALMIC	1 mg in 1 mL	5/30/2006
DERMFREE ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-006	NASAL	0.05 g in 100 mL	5/2/2025
Equaline Redness Relief Lubricant Eye Drops	United Natural Foods, Inc	83455-213	OPHTHALMIC	0.012 g in 100 mL	1/1/2024
Kroger Eye Drops Redness Relief	The Kroger Co.	30142-573	OPHTHALMIC	0.012 g in 100 mL	1/1/2024
Droptics Performance Eye Drops	Droptics LLC	85211-001	OPHTHALMIC	0.03 g in 100 mL	3/24/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
FLUCUR NEBULISER	SHIGAKEN PHARM IND CO LTD	SIN07343P	SPRAY	0.5 mg/ml	2/26/1993
NAZAL SPRAY	SATO PHARMACEUTICAL CO LTD	SIN03722P	SPRAY	50 mg/100 ml	11/6/1989
NAPHCON-A STERILE OPHTHALMIC SOLUTION	ALCON-COUVREUR NV, ALCON SINGAPORE MANUFACTURING PTE. LTD.	SIN04717P	SOLUTION	0.25 mg/ml	6/13/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
TELING EYE DROPS	N/A	SATO PHARMACEUTICAL CO.,LTD.	N/A	N/A	12/8/1992
REDISIL EYE DROPS	N/A	WELL FAVOURED LIMITED	N/A	N/A	1/27/2022

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
VISINE ALLERGY eye drops bottle	66073	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/17/1998
ALBALON-A eye drop bottle	23091	AbbVie Pty Ltd	Medicine	A	10/14/1991
ALBALON-A eye drop bottle	23091	AbbVie Pty Ltd	Medicine	A	10/14/1991
OPTREX EYE DROPS (reformulation) bottle	57571	Reckitt Benckiser Pty Ltd	Medicine	A	10/21/1996
NAPHCON-A eye drops bottle	47652	Alcon Laboratories Australia Pty Ltd	Medicine	A	1/24/1994
ALBALON naphazoline hydrochloride 1mg/mL eye drop bottle	23197	AbbVie Pty Ltd	Medicine	A	10/14/1991
MURINE RED EYES naphazoline hydrochloride 1 mg/mL eye drops ampoule	252112	Care Pharmaceuticals Pty Ltd	Medicine	A	7/30/2015
MURINE CLEAR EYES naphazoline hydrochloride 0.12mg/mL eye drops bottle	29589	Care Pharmaceuticals Pty Ltd	Medicine	A	10/21/1991
SYSTANE RED EYES naphazoline hydrochloride 1 mg/mL eye drops bottle	286697	Alcon Laboratories Australia Pty Ltd	Medicine	A	3/14/2017
NAPHCON FORTE naphazoline hydrochloride 1mg/mL eye drops bottle	10231	Alcon Laboratories Australia Pty Ltd	Medicine	A	7/4/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
R.O.-NAPHZ	richmond pharmaceuticals inc.	01901664	Liquid - Ophthalmic	.1 %	12/31/1992
CLEAR EYES EXTRA STRENGTH REDNESS RELIEF	prestige brands inc	02360837	Solution - Ophthalmic	0.03 % / W/V	4/27/2011
REFRESH EYE ALLERGY RELIEF	Abbvie Corporation	02315890	Solution - Ophthalmic	0.051 %	2/9/2009
REFRESH EYE ALLERGY RELIEF	Abbvie Corporation	02315890	Solution - Ophthalmic	0.51 %	2/9/2009
OPCON OPH SOLN 0.1%	bausch & lomb canada inc.	00750786	Drops - Ophthalmic	.1 %	12/31/1987
STERITEARS AR	laboratoires sterigen inc	02329875	Drops - Ophthalmic	0.05 %	N/A
STERITEARS AR	laboratoires sterigen inc	02329875	Drops - Ophthalmic	0.5 %	N/A
SOOTHE REDNESS	bausch & lomb inc	00764647	Drops - Ophthalmic	0.012 % / W/V	12/31/1988
REFRESH REDNESS RELIEF	Allergan, Inc.	02315920	Solution - Ophthalmic	0.1 %	2/9/2009
REACTINE EYE DROPS	mcneil consumer healthcare division of johnson & johnson inc	02237000	Drops - Ophthalmic	0.025 % / W/V	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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