Pheniramine
Naphazoline / Pheniramine, Naphcon-a, Opcon-a, Visine (pheniramine) is a small molecule pharmaceutical. Pheniramine was first approved as Naphcon-a on 1994-06-08. It is used to treat allergic rhinitis perennial, pruritus, and urticaria in the USA.
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Commercial
Trade Name
FDA
EMA
Combinations
Naphazoline pheniramine, Naphcon-a, Opcon-a, Visine
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 |
|---|---|---|
| alahist d | C200263 | 2024-07-09 |
| alahist dm | C200263 | 2024-11-09 |
| cvs pharmacy cold and sore throat | OTC monograph final | 2013-04-01 |
| equate eye allergy relief drops | ANDA | 2018-04-20 |
| eye allergy relief | New Drug Application | 2024-07-22 |
| naphazoline hci and pheniramine maleate | ANDA | 2020-12-28 |
| naphcon a | New Drug Application | 2024-08-22 |
| opcon-a | New Drug Application | 2023-12-14 |
| quality choice cold and sore throat | OTC monograph final | 2016-01-07 |
| scot-tussin original multi-symptom cold and allergy relief | OTC monograph final | 2015-10-15 |
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA16: Pheniramine
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AB: Substituted alkylamines, systemic antihistamines
— R06AB05: Pheniramine
HCPCS
Code | Description |
|---|---|
| J0945 | Injection, brompheniramine maleate, per 10 mg |
Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | 1 | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | 1 | — | 1 |
| Conjunctivitis | D003231 | — | H10 | — | — | — | 1 | — | 1 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 1 | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | 1 | — | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | 1 | — | — | 1 |
| Cold temperature | D003080 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Renal colic | D056844 | EFO_1001412 | N23 | — | — | — | — | 1 | 1 |
| Ureteral calculi | D014514 | — | — | — | — | — | — | 1 | 1 |
| Colic | D003085 | — | R10.83 | — | — | — | — | 1 | 1 |
| Ureterolithiasis | D053039 | EFO_1001228 | N20.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pheniramine |
| INN | pheniramine |
| Description | N,N-dimethyl-3-phenyl-3-(2-pyridinyl)-1-propanamine is a tertiary amino compound and a member of pyridines. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC(c1ccccc1)c1ccccn1 |
Identifiers
| PDB | — |
| CAS-ID | 86-21-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1193 |
| ChEBI ID | — |
| PubChem CID | 4761 |
| DrugBank | DB01620 |
| UNII ID | 134FM9ZZ6M (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Pheniramine
+
Naphazoline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 741 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,138 adverse events reported
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