What NDC numbers are and why my eye drops should have them

About NDC numbers

NDC stands for National Drug Code. An eye drop that has an NDC has fulfilled at least some of the requirements to be considered eligible for over-the-counter sales.

According to Federal law, all eye drops are considered drugs - either prescription drugs or over-the-counter drugs. As such, they are required to be registered with the FDA (or “listed”, in FDA-speak). The NDC code assignment takes place as part of the registration process.

Each NDC code has two or three sections:

  • The first five (or six) numbers represent the company behind the product. This may be the actual manufacturer, or it may be a distributor or “labeler”, for whom the product is being manufactured on a contract basis.
  • The next few numbers represent the unique product, such as Systane Complete PF.
  • There may be a third section if the product is packaged more than one way - for example if it is sold as a single bottle or as a pack of two.

Does my eye drop have an NDC number?

Check the box - it’s on most of them. If it isn’t, you can call the phone number on the box and ask for it.
If an eye drop does not have an NDC number, that means it is not registered (listed) with the FDA.

Why does this matter?

Having an NDC number is not a guarantee of safety or of a manufacturer’s or distributor’s compliance status. However, it does tell us that certain steps have been taking towards transparency on the part of the company.

When a company is knowingly manufacturing eye drops for sale in the US that are not registered with the FDA, this means the FDA does not know anything about them and the facility is not being inspected for compliance with CGMP (Current Good Manufacturing Practices). This can have serious safely implications.

Another reason why an eye drop may not have an NDC number is that it is being manufactured and packaged for sale in a country other than the US, but an individual or company is purchasing it for illegal import and sale in the US. When eye drops made for sale in other countries are available online through e-commerce, this typically means that the platform on which they are sold is not requiring sellers to prove that their OTC eye drops are authorized for sale in the US. In such cases, the origin of the product is less certain. For example, it may be authentic but stored improperly for long periods; it may have been relabeled; or it may even be counterfeit.

For these reasons, and due to escalating eye drop safety concerns, Dry Eye Foundation recommends against the purchase of eye drops that do not have an NDC number.