OTC Drug CDER Listing Compliance

I need to submit an over-the-counter (OTC) drug listing through the FDA’s CDER portal solely to satisfy federal compliance requirements. All dossier materials are ready in draft form; what remains is preparing and uploading the listing in the exact format CDER expects, then confirming that the submission has been accepted in the portal.

The listing must include these elements exactly as they appear on the finished label:
• Active ingredients
• Usage instructions
• Full labeling details (principal display panel, drug facts panel, and any required warnings)

Deliverables I will sign off on:
1. Correctly formatted SPL file (or other FDA-accepted format) containing the three information sets above
2. Successful upload to the CDER portal with a time-stamped confirmation receipt
3. A brief hand-off note explaining where the record can be accessed for future annual renewals

If you routinely navigate the CDER OTC listing workflow and can get this filed without delays, let’s move forward.