Naphazoline
Albalon, Nafazair, Naphazoline / Pheniramine, Naphcon, Naphcon-a, Opcon, Opcon-a, Vasocon, Vasocon-a, Visine (naphazoline) is a small molecule pharmaceutical. Naphazoline was first approved as Naphcon forte on 1982-01-01. It is used to treat hyperemia, rhinitis, and sinusitis in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Naphazoline pheniramine, Naphcon-a, Opcon-a, Visine (discontinued: Vasocon-a)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Naphazoline hydrochloride
+
Pheniramine maleate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NAPHCON-A | Alcon Research | N-020226 OTC | 1994-06-08 | 1 products, RLD, RS |
| OPCON-A | Bausch Health Companies | N-020065 OTC | 1994-06-08 | 1 products, RLD, RS |
| VISINE | Johnson & Johnson | N-020485 OTC | 1996-01-31 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 7 select redness relief | OTC monograph final | 2022-12-15 |
| advanced eye relief/ redness maximum relief | C200263 | 2024-09-25 |
| ak-con | ANDA | 2011-03-30 |
| alchemy 43 rescue redness relief | C200263 | 2024-03-08 |
| careone maximum redness relief eye drops | C200263 | 2023-12-23 |
| clear eyes complete 7 symptom relief | OTC monograph final | 2010-08-15 |
| clear eyes complete 7 sympton relief | C200263 | 2024-10-25 |
| clear eyes cooling itchy eye relief | C200263 | 2024-10-25 |
| clear eyes cooling redness relief | C200263 | 2024-10-25 |
| clear eyes maximum itchy eye relief | C200263 | 2024-08-21 |
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Indications
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Agency Specific
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ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AA: Sympathomimetics, plain
— R01AA08: Naphazoline
— R01AB: Sympathomimetics, combinations excl. corticosteroids
— R01AB02: Naphazoline
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GA: Sympathomimetics used as decongestants
— S01GA01: Naphazoline
— S01GA51: Naphazoline, combinations
HCPCS
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Clinical
Clinical Trials
30 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | — | 2 | 2 | — | 4 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 2 | 2 | — | 4 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | 2 | — | 2 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | 1 | 1 | 2 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | — | 1 | 1 | 2 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pterygium | D011625 | — | H11.0 | — | — | 1 | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | — | 1 |
| Nasal obstruction | D015508 | HP_0001742 | — | — | — | 1 | — | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | 1 | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | 1 | — | — | 1 |
| Cold temperature | D003080 | — | — | — | — | 1 | — | — | 1 |
| Ophthalmic administration | D060433 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fuchs' endothelial dystrophy | D005642 | EFO_0003946 | H18.51 | — | 1 | — | — | — | 1 |
| Hereditary corneal dystrophies | D003317 | HP_0007802 | H18.5 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Presbyopia | D011305 | — | H52.4 | — | — | — | — | 2 | 2 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | — | — | — | 2 | 2 |
| Intracranial hypertension | D019586 | EFO_1000992 | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Neck pain | D019547 | HP_0030833 | M54.2 | — | — | — | — | 1 | 1 |
| Vitreous detachment | D020255 | EFO_1001238 | H43.81 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Ocular vision | D014785 | — | — | — | — | — | — | 1 | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Naphazoline |
| INN | naphazoline |
| Description | Naphazoline is a medicine used as a decongestant. It is a sympathomimetic agent with marked alpha adrenergic activity. It is a vasoconstrictor with a rapid action in reducing swelling when applied to mucous membrane. It acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion.
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| Classification | Small molecule |
| Drug class | antihistamines/local vasoconstrictors (antazoline type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | c1ccc2c(CC3=NCCN3)cccc2c1 |
Identifiers
| PDB | — |
| CAS-ID | 835-31-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL761 |
| ChEBI ID | — |
| PubChem CID | 4436 |
| DrugBank | DB06711 |
| UNII ID | H231GF11BV (ChemIDplus, GSRS) |
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Financial
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Estimated US medical usage
Naphazoline
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Antazoline
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Naphazoline
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Naphazoline
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Pheniramine
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Safety
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4,090 adverse events reported
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