Frequently Asked Questions
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This section includes frequently asked questions about the application.
- CMO: Drug Manufactured Under Contract
- Windows 11 & SPL (update Microsoft Edge settings to view XML)
- What is SPL?
- Where do I find my OTC Monograph ID Number (Previously called OTC "Part Number"?
- Do I have to constantly save files from the Portal to my local machine?
- What does Pass/Fail Validation mean?
- How do you know if your Gateway Submission and/or ESG Submission has passed validation?
- How do you know when your submission has failed validation?
- How do I download my error message?
- Can you notify me when my submission has been uploaded to the NLM?
- When do I need to include an SPL file in my submission?
- What is the difference between XML and SPL?
- How many times do we need to update our listings?
- Why is my OTC product showing up on the Daily Med?
- What is the image size limit for the FDA?
- What is a manual override?
- Do I have to include all my inactive ingredients?
- How can I verify I am using the correct packaging term?
- After delisting an NDC, when can I reuse it?
- How can I change my user name?
- How do I change my password?
- How do I delist one of our products?
- Is it mandatory that I report source NDC's for our products?
- Does each of my submissions take up one of my licenses?
- Can I list two or more products together?
- How do I list a product that has multiple flavors?
- How many users are we allowed?
- What is the proper way to describe packaging?
- How come my SPL Portal Preview looks strange?
- Can I import SPL from an existing product in the Portal?