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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil PM is a fixed-dose combination OTC analgesic containing ibuprofen (NSAID) and diphenhydramine HCl (antihistamine/sleep aid) in oral capsule form. It is indicated for pain relief with nighttime sleep support. The ibuprofen inhibits cyclooxygenase to reduce inflammation and pain, while diphenhydramine provides sedation to facilitate sleep.
LOE Approaching
As an OTC product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely focused on line extensions and consumer loyalty rather than expansion.
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
Working on Advil PM offers exposure to mature OTC marketing and commercial execution within a stable, commoditized category. Career growth is limited compared to growth-stage products, with focus on operational efficiency and brand defense rather than innovation or team expansion.
Brand ManagerProduct 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.