The FDA Product Code identifies the type of regulated product being imported. It is separate from the HTS code used for customs classification.

Product Code structure

FDA Product Codes are built from five elements:

  1. Industry – two characters
  2. Class – one character
  3. Subclass – one character
  4. Process Indicator Code (PIC) – one character
  5. Product – two characters

Determine the Industry first, then move through the available class, subclass/process and product choices.

Basic process

  1. Open FDA's official Product Code Builder.
  2. Search using the generic product name or a meaningful keyword.
  3. Select the correct FDA Industry.
  4. Review the available Class choices.
  5. Select the Subclass and Process Indicator that accurately describe the product and process/packaging where applicable.
  6. Select the final product description.
  7. Compare the resulting code against the actual commercial product and invoice description.

Common mistakes

  • Using an HTS code as if it were an FDA Product Code.
  • Copying a code from another SKU with a different formulation, packaging or process.
  • Selecting the closest-sounding description without reviewing the hierarchy.
  • Choosing a code because it previously released quickly rather than because it accurately describes the goods.

Sources