Geoff LeCain

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 Contracts tab displays contract information. This information will include the Contract Name, Contract Type, the Contract Length (start/end dates) and if that Contract is currently active or no...

The “Contacts” tab displays all contacts that are associated with Labelers, Registrants, Establishments, and Authorized Agents.  To create a new contact, click the “Create New Contact” link. To...

The “Groups” tab contains information about all the groups that are defined in the system. Clicking on a row in the table, will populate the fields for editing.  New groups can also be created by c...

The “Practitioners” tab provides the user with the ability to search and create new practitioners in the application database. Users can search using the alphabetic filter or by clicking the “Show ...

Answer: You can also refer to the CFR to ensure that your OTC Monograph ID Number is correct:https://www.federalregister.gov/documents/2021/09/21/2021-20393/final-administrative-orders-for-over-the...