COLD CAPSULE V
LOE Approachingchlorpheniramine maleate; phenylpropanolamine hydrochloride
NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
COLD CAPSULE V (chlorpheniramine maleate; phenylpropanolamine hydrochloride). Approved for these symptoms due to hay fever, other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose and 1 more indications. First approved in 1985.
Drug data last refreshed 5d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cold Capsule V is an oral extended-release capsule combining chlorpheniramine maleate (first-generation antihistamine) and phenylpropanolamine hydrochloride (nasal decongestant) approved in 1985. It treats upper respiratory allergy symptoms including runny nose, itchy/watery eyes, sneezing, and throat itching associated with hay fever and allergic rhinitis. The antihistamine blocks histamine receptors to reduce allergic response, while the decongestant causes vasoconstriction of nasal blood vessels to relieve congestion.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling team focus likely transitioning to defensive strategies and cost management rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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