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 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVIL PM is a fixed-dose combination of ibuprofen (NSAID) and diphenhydramine HCL (antihistamine) delivered as an oral capsule for over-the-counter use. It is indicated for temporary relief of minor aches, pains, and fever, with the added benefit of a nighttime sleep aid. The ibuprofen component inhibits cyclooxygenase to reduce inflammation and pain, while diphenhydramine provides sedation to facilitate sleep.
LOE Approaching
As an OTC product approaching LOE with moderate competitive pressure (30), teams are likely focused on brand defense and efficiency 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 OTC portfolio management, retail channel strategy, and consumer brand defense in a highly competitive market. Career growth is typically lateral (moving to growth-stage brands) or upward into category leadership rather than vertical expansion within the product team.
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.