Monitor 151,000+ FDA drug products — prescription and OTC — with constant label change detection. Get instant alerts on safety-critical updates so your team can focus on patient safety and regulatory compliance.
Comprehensive monitoring and intelligence tools designed for pharmaceutical regulatory teams.
Continuously monitors DailyMed and OpenFDA for changes. Email alerts for safety-critical changes across 151,000+ prescription and OTC products in the FDA database.
AI-enhanced rules automatically classify changes into four severity tiers — Safety-Critical, Moderate, Minor, and Administrative — so your team can focus on what matters. Only publicly available FDA data is analyzed.
Color-coded comparison of old vs new label content. Section-by-section navigation with exportable change reports for your compliance records.
Automatic RLD linking for ANDAs. Brand-generic tracking with Orange Book TE codes, patent data, and exclusivity monitoring.
TE code change alerts with high urgency classification. Patent expiration tracking on a 180-day horizon and new drug approval notifications.
Drug recall tracking across Class I, II, and III. Adverse event signals from FAERS data and FDA safety communications integrated into your workflow.
Get started in minutes with a straightforward setup process.
Search 151,000+ FDA products — both prescription and OTC — and organize by therapeutic area, manufacturer, or application type. Add ANDAs and their RLDs are linked automatically.
Set notification preferences, severity thresholds, and delivery frequency. Choose real-time, daily, or weekly digest formats for your team.
Receive actionable alerts when changes occur. Review visual diffs, track recommended FDA actions, and maintain a complete audit trail.
Built for regulated industries from day one.
E-signatures, immutable audit trails, and comprehensive access controls for FDA compliance.
Data export, right to erasure, IP anonymization, and configurable retention policies.
Multi-factor authentication, AES-256 encryption at rest, and password breach checking.
REST API with OpenAPI 3.0 documentation, webhook support, and SSO (SAML 2.0, OAuth).
Purpose-built tools for pharmaceutical regulatory professionals.
Monitor RLD label changes for ANDA submission prep. Automatic brand-generic linking with Orange Book intelligence for TE codes, patents, and exclusivity.
Track your own labels and the competitive landscape. Post-marketing surveillance with FDA recall monitoring and adverse event signal detection.
Centralized monitoring with review workflows. Role-based access, 21 CFR Part 11 compliance, and complete audit trails for inspection readiness.
Everything you need to know about LabelMonitor and FDA label monitoring.
LabelMonitor directly integrates with the FDA's official DailyMed database and openFDA API, covering both prescription and OTC products. We pull from the most authoritative source for drug labeling information in the United States. Our system continuously checks for updates to ensure you're always working with current information.
When a label change is detected, AI reviews the publicly available FDA label text to distinguish cosmetic or formatting changes from substantive content updates. This helps classify changes into four tiers — Safety-Critical, Moderate, Minor, and Administrative — so your team can focus on what matters most. Only publicly available data from DailyMed and openFDA is processed; no proprietary, patient, or confidential data is ever involved. AI assists the classification system to reduce noise and improve accuracy, but it does not replace regulatory judgment — all results are presented for human review.
Our system continuously scans FDA data sources for changes. When a label change is detected, it goes through both structural analysis and AI-enhanced review before being classified by severity. For critical safety updates (boxed warnings, contraindications), we prioritize detection and notification. You can configure immediate, daily, or weekly digest delivery.
LabelMonitor is built with pharmaceutical compliance requirements in mind. We implement AES-256 encryption at rest with field-level encryption, TLS 1.3 in transit, multi-factor authentication, and comprehensive audit logging. Our platform is designed for 21 CFR Part 11 compliance with immutable audit trails and electronic signatures, plus GDPR-ready architecture with IP anonymization and data export capabilities.
Early access includes up to 25 products monitored, 3 team members, 3 portfolios, 90-day alert history, and full alert options (real-time, daily, or weekly digests). You'll also get label change diffs, FDA recall monitoring, Orange Book tracking, and priority support. Early access users have the opportunity to shape the product roadmap.
Yes. LabelMonitor offers a REST API with OpenAPI 3.0 documentation, webhook notifications for real-time updates to your systems, and email alerts that can be routed to your existing ticketing or workflow systems. We also support SSO (SAML 2.0, OAuth) for enterprise authentication.
LabelMonitor tracks Therapeutic Equivalence (TE) codes, patent listings with expiration dates, and exclusivity periods from the FDA Orange Book. TE code changes trigger high-urgency alerts. Patent expirations are tracked on a 180-day horizon, and new drug approvals generate notifications. This data is automatically linked to your ANDA portfolio for comprehensive brand-generic intelligence.
Yes. LabelMonitor ingests all OTC drug labels from DailyMed alongside prescription products. Label change detection, severity classification, visual diffs, and alerting work identically for OTC products. OTC-specific features like Drug Facts label tracking are fully supported. Note that Orange Book and RLD linking features are specific to prescription drugs (NDA/ANDA), as OTC products follow a different FDA regulatory pathway.