NDAORALCAPSULE
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ADVIL PM (diphenhydramine hcl, ibuprofen) by GSK is cyclooxygenase inhibitors [moa]. First approved in 2005.
Drug data last refreshed 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVIL PM is a fixed-dose combination of ibuprofen (NSAID) and diphenhydramine HCl (antihistamine) formulated as an oral capsule for over-the-counter use. It is indicated for temporary relief of minor aches and pains with accompanying sleeplessness. The ibuprofen provides cyclooxygenase inhibition for anti-inflammatory and analgesic effects, while diphenhydramine induces somnolence to facilitate sleep.
LOE Approaching
As a mature OTC product approaching loss of exclusivity, the brand team is likely focused on defensive line extensions and cost optimization rather than aggressive growth initiatives.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
ADVIL PM offers limited career acceleration opportunities due to its mature, declining lifecycle stage and OTC classification. Roles on this product are primarily commercial/retail-focused, emphasizing cost management, promotional effectiveness, and retail distribution rather than clinical innovation or pipeline advancement.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.