Over-The-Counter Drug Registration

Overview

INVICTA Nutraceuticals is a registered OTC drug manufacturer and labeler with the FDA (Manufacturer Registration No. 3032196082, Labeler Code: 84750). Whether you’re developing a new product, using one of our white-label options, or bringing an existing product to market, we offer comprehensive services that ensure regulatory compliance and deliver high-quality packaging and marketing solutions tailored to your needs.

Comprehensive Registration Process

Initial Consultation

We begin by understanding your product needs, whether you're developing a new formula, utilizing a white-label solution, or enhancing an existing product. During this phase, we establish timelines, deliverables, and discuss branding guidelines, including logos and design specifications.

Label and Packaging Design

Our team creates regulatory-compliant labels and packaging that reflect your brand identity and meet FDA requirements. This includes the Drug Facts Panel, appropriate warnings, usage directions, and correct NDC code placement. We also offer custom packaging designs to enhance your product’s visual appeal and ensure marketing materials align with regulations.

NDC Number Assignment and FDA Registration

Each product receives a unique 10-digit NDC number (e.g., 84750-XXXX-XX). We handle the registration through the FDA’s electronic Drug Registration and Listing System (eDRLS), ensuring your product’s NDC number is publicly accessible and in compliance with FDA regulations.

Distinctive Packaging Solutions

We offer custom designs and packaging solutions that elevate your product’s shelf appeal. With professional craftsmanship and attention to detail, we ensure your packaging stands out and reflects the quality of your product.

Compliance Review for Client-Provided Artwork

For client-provided labels and packaging, we conduct a meticulous compliance review to ensure they meet all FDA standards. This step minimizes the risk of rejection or penalties, confirming your product’s regulatory adherence.

Final Documentation

Upon completion, we provide finalized documentation, including an FDA Registration Certificate, NDC number confirmation, and links to public listings such as the FDA and DailyMed databases.

Where Your Product Will Be Searchable

FDA Public Database

Your product will be searchable by NDC number, product name, and manufacturer in the FDA Public Database, ensuring full transparency and compliance with federal regulations. FDA Database

National Institutes of Health (NIH) DailyMed

Listed on DailyMed, your product’s detailed Drug Facts, active ingredients, and warnings will be accessible to healthcare professionals, researchers, and consumers. DailyMed Database

Global Compliance Databases

Your product’s NDC number and registration details will also be referenced in international databases that rely on FDA data.

Why Choose INVICTA Nutraceuticals?

  • FDA Registered and Experienced: Fully compliant as both a manufacturer and labeler.

  • Comprehensive Service: From compliance checks to packaging, we handle every step.

  • Flexible Options: Tailored services to fit your brand’s specific needs.

  • Broad Accessibility: Your product will be prominently listed on key regulatory and healthcare platforms.

  • Expert Guidance: We help you navigate the complexities of allowable claims and marketing language, ensuring adherence to regulatory guidelines.