The short answer
Every FDA-regulated line on a U.S. customs entry carries an FDA product code — a 5- to 7-character code that tells FDA exactly what the product is — and, depending on the product, one or more Affirmation of Compliance (AofC) codes that point FDA to the registration, listing or filing behind it. Wrong codes are one of the easiest ways to get a shipment held for review, because FDA’s screening system (PREDICT) scores each line on this data.
How an FDA product code is built
| Part | Characters | Example (38BEE27) |
|---|---|---|
| Industry | 2 numbers (02–98) | 38 — Soup |
| Class | 1 letter | B — Soup, concentrated |
| Subclass | 1 letter or hyphen — container or packaging | E — Metal container |
| Process Indicator Code (PIC) | 1 letter or hyphen — process, storage or dosage form | E — Commercially sterile |
| Product | 2 letters or numbers | 27 — Tomato soup, concentrated |
Use FDA’s online Product Code Builder to build the code. FDA expects the code to match the product name and invoice description.
Common Affirmation of Compliance codes
| Code | Meaning | Used for |
|---|---|---|
| PFR | Manufacturer’s food facility registration number | Food |
| FME | Food facility registration exemption, with a reason code | Food from an exempt facility |
| FCE | Food Canning Establishment number | Low-acid canned and acidified foods — see FCE and SID |
| SID | Submission identifier for the process filing | Low-acid canned and acidified foods |
| COS | Cosmetic registration number | Cosmetics |
| REG / DLS | Drug establishment registration number / drug listing number or NDC | Drugs — see NDC numbers |
| DEV / LST | Device foreign manufacturer registration / device listing number | Medical devices |
| PM# | Premarket number, such as a 510(k) (K…), PMA (P…) or De Novo (DEN…) | Medical devices |
FDA’s official list (March 10, 2026) warns that declaring a code that is not on the list results in an entry rejection. Some codes are mandatory for certain products; FDA says sending voluntary codes along with the mandatory ones may speed up screening.
What exporters should send their broker
- 1A product list with codesOne FDA product code per product, built in the Product Code Builder and matching the invoice description.
- 2Registration numbersFood facility registration, cosmetic registration, drug or device registration — whatever applies to the manufacturer.
- 3Product-level numbersFCE and SID for canned foods, NDC for drugs, listing and 510(k) numbers for devices.
- 4Prior Notice details for foodFiled before arrival. See Prior Notice filing.
Example: canned tuna from Thailand
A Thai canner exports tuna in oil in cans. It gives its U.S. customs broker one product code built for canned fish in a metal container with a commercially sterile process, its food facility registration number for PFR, and its FCE and SID numbers for the specific can size and process. Each invoice line uses the same product name as the code description, so FDA’s screening system has nothing to question.
FDA food facility registration with U.S. Agent from $300. FCE registration assistance $550. SID process filing $350. Prior Notice $15 per shipment.
Frequently asked questions
Who chooses the FDA product code?
The entry filer (usually the customs broker) submits it, but the exporter and importer know the product best and should supply it.
How many characters is an FDA product code?
Five to seven, made of industry, class, subclass, process indicator and product parts.
Are Affirmation of Compliance codes mandatory?
Some are mandatory depending on the product; others are voluntary but may speed up screening. A code not on FDA’s list causes an entry rejection.
What AofC codes do canned foods need?
Low-acid canned and acidified foods use FCE (Food Canning Establishment number) and SID (process filing identifier).
Sources
- FDA — Product codes and Product Code Builder
- FDA — Affirmation of Compliance codes
- FDA — ACE Affirmation of Compliance codes list (March 10, 2026)
Codes checked on November 12, 2026. This article is general information, not legal advice.