Attention Brand Owners and Manufacturers / Contract Manufacturers of Over-The-Counter (OTC) drugs

US FDA Annual Product Registration Deadline was December 31, 2020 for all OTC Products!

Contact us today! Our experts are here to help you with your past due FDA registrations.

Be sure you know and understand the classification of your product. Did you know Salicylic Acid or an SPF or fluoride may classify your product as an Over-The-Counter (OTC) drug in the US? There are other ingredients that can change the product classification, so let us know and we will help you confirm where your product fits.

We work with a number of common Over-The-Counter (OTC) drugs, including:

FDA registrations are required annually and can be quite confusing at times. We have been working with the FDA for over 20 years and know all of the “ins and outs” of these submissions. And, our rates are among the lowest for these services.

Facility registrations as well as Product Registrations were due December 31, 2020 for the 2021 year. If you miss a deadline, the product will be out of compliance/illegal. Incoming product will be held at US Customs causing daily storage fees or destruction. And worse, the company may be Red Listed causing FDA inspections with every shipment before release. So avoid the rush and call us today!

Here are answers to some of the questions you may have about FDA registrations:

Annual FDA Registration are required for the following:

When should we start this registration???

How Long does it take?

What happens if the deadline is missed?

Let us know how we can be of assistance with your OTC drug registrations.