FDA Label Compliance, Made Simple

Get compliance-ready product labels in under 48 hours, powered by AI and designed for industries where precision matters.

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Why us

Where Accuracy Meets Automation

Our platform combines speed, accuracy, and affordability - helping regulated industries stay compliant without the usual complexity.

01

Fast Turnaround

Get detailed compliance reports in less than 1 week.

02

AI Accuracy

Advanced OCR + NLP ensures you catch what others miss.

03

Affordable

Fair pricing for businesses of all sizes — 
no consultants needed.

04

User-Friendly

No training required. Just upload your label and go.

05

Built for Regulated Industries

Perfect for food, supplements, cosmetics, drugs, and more.

How it Works

3 Simple Steps

We make label compliance fast and intuitive with a seamless process that takes you from upload to report in 3 simple steps. No expertise required.

Step 1

Upload Your Label

Drop in your product label (JPG, PNG, or PDF – up to 10MB).

Step 2

AI-Driven Analysis

Our system checks against FDA requirements, flagging potential issues like formatting errors, banned ingredients, and missing info.

Step 3

Get Your Compliance Report

Within 48 hours, receive a downloadable PDF report with actionable insights, AI suggestions, and a compliance summary.

Security & Privacy

Protecting Your Data, End to End

LabelRX is designed with HIPAA-compliant infrastructure, encryption, and full data control to protect your sensitive label and user data.

HIPAA-Compliant Cloud Storage

(AWS or GCP)

User-Controlled Access

You own your data and control who sees it.

HIPAA-Compliant Cloud Storage

Transparent data handling, always.

Audit Logs

Every action is tracked for full traceability.

Trusted Cloud Providers

Hosted securely on AWS or GCP.

What We Do

What Can LabelRX Check

Whether you're in food, supplements, cosmetics, or pharmaceuticals, LabelRX analyzes your label against FDA-specific requirements.

Food & Supplement
Labels

Validate ingredients, supplement facts, allergen statements, and more

OTC Drug
Labels

Check Drug Facts formatting, dosage warnings, and required statements.

Cosmetic Product
Labels

Check Drug Facts formatting, dosage warnings, and required statements.

Veterinary
Products

Validate ingredients, supplement facts, allergen statements, and more

What Our Users Say

“LabelRX was a game-changer. We received a fully compliant, print-ready label in just over 24 hours, allowing us to launch our new product line a full month ahead of schedule. A must-have for any startup.”

Jessica C.

Founder & CEO

“In our industry, precision is non-negotiable. The LabelRX AI caught a critical compliance error that our manual review team had missed. It’s more than just fast—it’s an essential tool for risk reduction.”

Carlos R.

Head of Operations

“As a contract manufacturer, LabelRX has been revolutionary. It cut our label revision time by over 70% and standardized our process, allowing us to scale our client services efficiently and without error.”

David M.

Director of Regulatory Affairs

“LabelRX bridges the gap between our marketing and regulatory teams. We get near-instant feedback on claims and receive approved labels in days, not weeks. Our entire launch process is simply faster now.”

Samantha E.

Senior Brand Manager

Ready to Make Your Labels FDA-Compliant? Let’s Get Started!

General FAQs

What is LabelRx?

LabelRx is an AI-driven compliance platform that simplifies FDA regulatory reviews for health and wellness product labels. It helps businesses ensure their packaging and marketing materials meet FDA requirements with speed, accuracy, and peace of mind.

How does LabelRx work?

LabelRx uses advanced AI (including OCR and NLP) to scan your product label, extract relevant data, and run it through a compliance engine mapped against the latest FDA guidelines. You receive an instant, detailed report outlining any regulatory risks or suggested changes.

Can LabelRx help with international compliance?

At this time, LabelRx is U.S.-FDA focused. However, we are planning Phase 2 expansions to include international standards like Health Canada and EMA (Europe).

Is the AI reliable for regulatory interpretation?

LabelRx is trained on FDA documentation, warning letters, and compliance case law. Every review is backed by explainable AI logic and citation links to relevant FDA sources. However, for final legal sign-off, we recommend review by your regulatory advisor.

Does LabelRx offer human compliance review?

Yes. Users can optionally request a human compliance specialist to review the AI report and provide a final recommendation for high-risk products.

View Full FAQs

Ready to Make Your Labels FDA-Compliant? Let’s Get Started!