FDA COMPLIANCE · IMPORTS AND PRIOR NOTICE
Quick answer
An FDA product code is a five to seven character code that tells FDA exactly what an imported product is. It has five parts: a two-digit industry code, a class letter, a subclass, a process indicator code (PIC) and a two-character product group. You build it with FDA’s free Product Code Builder, and it goes on every FDA line of an import entry and on every Prior Notice for food. A code that does not match the label, invoice and intended use is one of the easiest ways to slow down a shipment.
What an FDA product code is not
- It is not a registration number, an FEI number or an NDC.
- It is not the same thing as a cosmetic product category code in Cosmetics Direct, or a three-letter device classification code on its own.
- It is not a sign that FDA has reviewed or cleared the product.
Updated November 2026. If you import food, supplements, cosmetics, OTC drugs or devices to sell on Amazon, Walmart, TikTok Shop or Shopify, someone in your supply chain has to pick an FDA product code for every product on every shipment. Often a customs broker picks it from your invoice, and vague invoice names lead to guesses. This guide shows how the code is built and how to check it yourself. It is general information, not legal advice.
Table of Contents
- What is an FDA product code?
- How is an FDA product code structured?
- How do you use the FDA Product Code Builder?
- Which industry codes do ecommerce brands usually start from?
- How is the import product code different from the codes in Cosmetics Direct and the device database?
- Where does the product code show up in Prior Notice and import entries?
- What happens if the product code is wrong?
- How Eva Commerce helps with product codes and Prior Notice
- Frequently asked questions
What is an FDA product code?
FDA describes a product code as a combination of five to seven numbers and letters that describes a specific product. The code submitted with each FDA line item should match the actual product name or the invoice description. FDA uses it to route the entry to the right program and decide what to review.
For food, the code is also a required field in Prior Notice. Under 21 CFR 1.281, every Prior Notice must identify the article of food with “the complete FDA product code,” along with its common or usual name, the quantity and, where required, lot or code numbers.
How is an FDA product code structured?
Every code has the same five components, read left to right:
- Industry code: two numbers from 02 to 98. This is the broadest group, such as soups, fishery products, cosmetics, or a medical device panel.
- Class: one letter tied to the industry. It narrows the product by food group, source, use, category or pharmacological action.
- Subclass: one letter or a hyphen. It usually describes the container or the material that holds the product. Medical devices use a hyphen here.
- Process indicator code (PIC): one letter or a hyphen. It describes the process, storage or dosage form. Medical devices, cosmetics and some animal products use a hyphen.
- Product (group): two letters or numbers that identify the specific product within that industry and class.
FDA’s own examples make the pattern clear:
- 38BEE27: concentrated canned tomato soup (industry 38 soup, class B concentrated soup, subclass E metal container, PIC E commercially sterile, product 27 tomato soup).
- 62GBA41: ibuprofen (industry 62 human and animal drugs, class G anti-inflammatory, PIC A prompt release tablets, product 41 ibuprofen).
- 79L–RR: a first aid kit that includes drugs (industry 79 general and plastic surgery, class L kit, two hyphens, product RR).
How do you use the FDA Product Code Builder?
The Product Code Builder is a free FDA web application. It walks you through each component and only offers valid choices for the parts you have already picked. A practical routine looks like this:
- Gather the facts first. Have the label, ingredients, container type, processing or storage method and dosage form ready. FDA says the easiest way to get the code right is to know the product itself.
- Pick the industry. Start from what the product is, not how you market it. A collagen powder sold as a supplement starts in a different industry than a collagen face cream.
- Choose class, subclass and PIC. If you do not know the processing method, ask the manufacturer.
- Choose the product group. Check that the description FDA shows matches the product name on your invoice.
- Record the result. Save the full code, the FDA description and your reasoning in a product sheet for each SKU, so every shipment uses the same code.
FDA also publishes a seven-lesson tutorial. Lesson 4 covers food, cosmetic and vitamin products, and Lesson 7 covers medical devices.
Which industry codes do ecommerce brands usually start from?
A few industries come up again and again for online brands:
- Dietary supplements, vitamins and protein powders usually sit in industry 54, vitamins, minerals, proteins and unconventional dietary specialties.
- Cosmetics such as skin care, makeup, hair care and fragrance sit in industry 53. Cosmetics have no PIC, so that position is a hyphen.
- OTC drugs, including sunscreens, acne products and pain relievers, sit in the drug industries, with the PIC describing the dosage form.
The trap is the borderline product. A serum with drug claims or a sunscreen moisturizer can land in a different industry depending on intended use and claims. If the label and the code disagree, fix one of them before the goods ship.
How is the import product code different from the codes in Cosmetics Direct and the device database?
Sellers often mix up three different “product codes”:
- Import product code (this article): the five-part code built in the Product Code Builder for entries and Prior Notice.
- Cosmetic product category code: used in MoCRA product listing in Cosmetics Direct. It looks different. A rinse-off hair conditioner is 06A2 and a bubble bath is 02B. See our guide to MoCRA product listing in Cosmetics Direct.
- Device product code: a three-letter code from FDA’s device Product Classification database, used in device listing. In the import code, the class letter plus the two-letter product group form that same three-letter device code, which is why 79L–RR maps to the first aid kit code LRR. Our medical device registration and listing guide covers the listing side.
An NDC is different again. It identifies a specific drug product and package, and it comes from drug listing. See how to get an NDC number for an OTC product.
Where does the product code show up in Prior Notice and import entries?
For food, including supplements and pet food, the product code is part of the product identity in every Prior Notice, next to the common name, quantity and manufacturer details. Our FDA Prior Notice guide walks through the full filing, and our answer on Prior Notice for Amazon FBA shipments covers the marketplace angle.
For all FDA-regulated goods, the product code goes with each FDA line in the customs entry, and FDA’s review starts from it. A code that disagrees with the label, invoice or product invites a closer look.
What happens if the product code is wrong?
A wrong code does not always stop a shipment, but it adds risk: document requests, holds, sampling, or refusal if FDA decides the product does not meet requirements. For food, a Prior Notice with wrong identity information can be treated as inadequate, and food with inadequate Prior Notice is subject to refusal and held. If you are already dealing with a hold, read what to do when FDA detains a shipment.
Mistakes we see most in ecommerce supply chains:
- One code reused for every SKU in a mixed carton, even when the products are different types.
- A supplement coded as a conventional food, or a cosmetic coded as a drug, because the invoice used marketing names.
- A PIC or subclass picked at random because nobody asked the manufacturer how the product is made or packed.
- Codes copied from a supplier’s old shipments after the formula or claims changed.
How Eva Commerce helps with product codes and Prior Notice
Eva Commerce files Prior Notice for food and supplement shipments and reviews labels, and both depend on getting the product identity right. We build or check the FDA product code for each SKU, match it to the label and invoice, and keep it on file so the same code goes on every shipment. We also act as U.S. Agent for foreign facilities ($250 a year) and handle facility registration and product listing filings, with prices on our FDA compliance services page.
Because the same team runs Amazon management, we can line up import paperwork with your inbound plan. A product code is an identification step. It does not mean FDA has approved, cleared or endorsed a product. Book a call or call 858-315-2020 to review your SKUs before the next shipment.
Frequently asked questions
What is the FDA Product Code Builder?
It is a free FDA web application that guides you through the five parts of an FDA product code (industry, class, subclass, PIC and product group) and only shows valid choices for each step.
How many characters is an FDA product code?
Five to seven characters. Positions that do not apply, such as the subclass and PIC for medical devices or the PIC for cosmetics, are filled with hyphens.
Is a product code required for FDA Prior Notice?
Yes. Under 21 CFR 1.281, each Prior Notice must include the complete FDA product code for the article of food, along with its common name, quantity and other details.
What industry code do dietary supplements use?
Most supplements, vitamins and protein powders are coded in industry 54, vitamins, minerals, proteins and unconventional dietary specialties. The exact class and product group depend on the product.
Is the FDA product code the same as a cosmetic category code?
No. The import product code is used for entries and Prior Notice. Cosmetic category codes such as 06A2 are used for MoCRA product listing in Cosmetics Direct.
Can Eva Commerce check my FDA product codes?
Yes. Eva builds or checks product codes as part of Prior Notice and label review work and keeps them on file for each SKU. Book a call or call 858-315-2020.
Sources: FDA, Product Codes and Product Code Builder; FDA, Product Code Builder application; FDA, PCB Application Content; FDA, Cosmetic Product Categories and Codes; FDA, Product Classification database; FDA, Prior Notice of Imported Foods; 21 CFR 1.281. General information, not legal advice.