Product Code Builder Help
Frequently Asked Questions
Click on a question below to view the answer:
You have four options to begin using the Product Code Builder.
- Option 1 - Search Industry
Scroll through the list of industries and select the one that is most closely related to the product you are coding. You may select more than one industry by holding down the CTRL key as you make your selections. When you're ready, click the NEXT button. The drop down lists on the next screen will be limited to those that match the Industry you entered.
- Option 2 - Search Partial Code
To search on a partial code, you must enter a valid industry code and any other parts of the product code in the appropriate fields. Click NEXT. Your choices for the remaining fields will be limited to those that match the industry code and any other field(s) you entered.
- Option 3 - Search Product Name
This is the quickest way to find a Product Code.
Enter a word from the product name or a keyword associated with the product name.
For example, if you are coding swordfish you can enter 'sword' 'fish', or 'swordfish.' If you are coding bottled spring water you can enter 'spring' or 'water.' If you enter multiple words, they must be found in the product name or description in the same order you entered them. It's usually best to search on one keyword at a time.
Click NEXT. On the next screen, all industries with a product or products that contain entries with the word you specified will be listed. Click on the drop down list of Product Names for the Industry or Industries that match the product you are coding.
- Option 4 - Verify Product Code
If you have a product code, and want to know if it is still a valid code or if you are not sure what product it represents, you can enter the code in the appropriate fields. Click NEXT. If the product code is valid, the name of the product will appear on the next screen. The Application returns the primary product for the product code entered. There may be secondary products with this product code. To view primary and secondary products for this product code, use Option 2.
The suggested display setting is as follows:
Color Palette: Hi Color (16 bit) or better
Desktop area: 800x600 pixels or better
Font size:small fonts
To change your display settings, Click Start, Settings, Control Panel. In Control Panel, click the Display icon. Then click Settings and enter the appropriate changes.
The product code builder application and the tutorial will open in a new window on top of the main page. You can maximize the window by clicking the middle button in the upper right hand corner of the window.
The FDA Product Code is seven characters long and is broken into the following fields:
- Industry
- Class
- Subclass
- Process Indicator Code
- Product
The Industry, Class and Product combine to identify a particular product. All products currently coded by the FDA are part of the application. The Subclass codes vary based on the industry selected; these can be types of packaging or can serve to further identify the product selected. The PIC identifies the process most recently used to create the product being imported.
Certain products (medical devices and radiation-emitting devices) do not have Subclass or PIC codes. A hyphen ('-') will automatically be entered in these two fields when one of these products is selected. Furthermore, medical devices are not separated by Class codes; the Class code is combined with the Product code to make a three-character code which uniquely identifies a medical device for a given industry.
To learn more about how the FDA Product Code is structured, go the Training Module and click on Lesson 3 - The Structure of the FDA Product Code.
The first two characters of the FDA Product code represents the various industries regulated by the FDA. It is always numeric.
To learn more about the industries regulated by the FDA, go the Training Module and click on Lesson 1 - FDA Regulated Industries.
The third character of the FDA Product Code designates the food group, source, product, use, pharmacological action, category or animal species of the product. It is always an alpha character.
To learn more about the Class Codes associated with specific industries, go the Training Module and click on any of the industry specific Lessons - 4, 5, 6, or 7.
The fourth character of the FDA Product Code represents the container type, method of application, use, market class, or type of product. It is always an alpha character or when it is not used a hyphen (-) is displayed instead.
To learn more about the Subclass Codes associated with specific industries, go the Training Module and click on any of the industry specific Lessons - go the Training Module and click on any of the industry specific Lessons - 4, 5, 6, or 7.
The fifth character of the FDA Product Code is the Process Indicator Code, or PIC. It designates the process, storage method, or dosage form. It is always an alpha character or hyphen (-) is displayed instead.
To learn more about the Subclass Codes associated with specific industries, go the Training Module and click on any of the industry specific Lessons - 4, 5, 6, or 7.
The last two characters of the Product Code represent the specific product, product group, generic drug name, feed source or animal species. It is dependent on the Industry Code and Class Code selected and can be alpha or numeric. There are over 13, 000 products in the Product Code database.
Review the information provided by the manufacturer or exporter. This includes product label, invoice papers, or entry documents. This information will be helpful to you as you select each element of the Product Code. When in doubt, contact the manufacturer or importer for more information.
Each product name is identified by a product code that consists of five digits (2 numeric, 3 alpha). The codes for these products are found in a Department of Health and Human Services publication entitled 'Classification Names for Medical Devices and In-Vitro Diagnostic Products.' The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is responsible for assigning the codes. These codes are part of the OASIS database that is used by the Product Code Builder application.
The first two digits of these product codes indicate the medical specialty under which the device was originally classified (i.e., dental, obstetrics, microbiology, etc.). The first letter of the classification code assigned by FDA goes under Product Class. However, this does not give the Product Class any specific meaning. The last two letters of the classification go under Product. Subclass and PIC codes are not used for these products; hyphens are entered in those two fields.
When you code these products, try searching for the name of the product first. If your first search does not provide the description of the product you are attempting to code, try searching for other key words that describe the product. This process should lead you to the correct Product Code.
The product codes for Non-Medical Radiation Emitting products are similar to those for Medical Devices and In-Vitro Diagnostic Products. Each product name is identified by a product code that consists of five digits (2 numeric, 1 alpha and 2 numeric). The codes are the responsibility of the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). These codes are part of the OASIS database that is used by the Product Code Builder application.
The Non-Medical Radiation Emitting Industries cover twenty-five products. The alpha character of the classification code assigned by CDER goes under Product Class. However, this does not give the Product Class any specific meaning. The last two numbers of the classification go under Product. Subclass and PIC codes are not used for these products, hyphens are entered in those two fields.
When you code these products, try searching for a keyword associated with the product. Often, this will quickly lead you to the Product Code.
Generally, Option 3 - Search Product Name is the easiest method to use to find a product code. When you enter the name or a key word associated with the product name, the Product Code Builder application will return all products in the database that match the name or key word entered.