Geoff LeCain

Answer: Yes, we now have an Establishment repository in the Portal that is updated periodically. You can view this list by following the steps below: Click the “Contacts/Entities” menu button Clic...

The Labeler & Registrant tab allows users to associate and manage the Labeler Code and if necessary the Registrant for the product. Registrants that are marked as confidential will not display on ...

Answer: Select the Actions drop-down menu and select Contact Us to send a question, report a bug, suggest a new feature, or add an ingredient approved by the FDA not found in our database. Simply s...

The “Establishments” tab allows users to associate Establishments and business operations with the product. Establishments that are marked as confidential will not display on the public Daily Med...

Answer: When entering data into the Product Data Elements section, specifically the proprietary and Establishment name fields, spelling conventions should remain consistent. The proprietary and Est...

The “Product Data Elements” section allows users to further define each manufactured product.  The “Product Validation” section displays the result of the last validation for all of the data in the...

Answer: The SPL style sheet populates the table of contents with the text associated with the “Title” elements of each major section. To prevent the “Recent Major Changes” text from showing in the ...

  The individual manufactured product is broken down into 6 distinct areas: Manufactured Product Active Ingredients – Basis of strength, active moiety, codes, etc. Inactive Ingredients –ratio, co...

Answer: The SPL schema does not support centering tables, therefore, the SPL Portal application does not allow for a table to be centered in relation to the body of the document. The text in the ce...

The “Active Ingredients” section allows users to define the active ingredient based on the FDA rules.  Users should define the basis of strength, active ingredient, strength, and active moiety.  Th...