Geoff LeCain

The “Change Password” option allows users to change their current password. Passwords must follow the following rules: Consist of 8 to 20 characters Contain at least 1 letter Contain at least 1 nu...

Click the “Help” option from the “View” drop-down menu to display the on-line Help files.  The Help topics will open in a separate browser window. The help content is searchable.

If your submission has a status of “Ready to Submit” and you have added the FDA Submissions Gateway to your account, a green arrow will appear in the “Submit to FDA Gateway” column (Red Box). If y...

By default, My Checked Out Products tab is displayed when the Product page is first opened.  If the user does not have any checked out products, then the product list tab is displayed.  The My Chec...

The “Addresses” tab displays all addresses that are associated with labelers, registrants and Establishments. To create a new address, press the “Create New Address” link (red box). To edit an ...

The NDC Directory Search tab allows a user to search the DailyMed by NDC code. Enter a valid NDC code and press the Find Label(s) button to find all labels matching the NDC code.  

The “Distribution Detail” tab allows a user to view or create a new sample distribution by associating product and a package with a practitioner and a manufacturer.  Recent distributions associated...

Answer: SPL(Structured Product Labeling), SPL standard is a Health Level Seven, Inc. standard for the exchange of product information using extensible markup language (XML). 

The “Contact Us” option provides users with a way to communicate via email with the SPL Portal support team. Select a subject area and enter your text in the “Body” area. There are four pre-defin...

The Product Licenses tab displays contract information about the licenses.  Below is a summary of the columns displayed in the Product Licenses grid. Sixty (60) days before a contract term expire...