1. Missing folder - Place each SPL document and any associated image file(s) in a folder and upload the folder containing the SPL and image files via the FDA Gateways OC directory.
  2. Incorrect or missing file extension  The file extension for SPL documents is . and the file extension for image files is .jpg.
  3. Incorrect file format  Winzip (zipped files) Excel, PDF, Word, and eCTD files are not acceptable formats for documents submitted for the purpose of electronically registering a drug establishment, submitting or requesting a NDC labeler code, or listing a drug product via the FDA OC Gateway. Only and JPEG (jpg) file formats are acceptable.
  4. Submitting more than one file per folder  Only one SPL file should be included in each folder.
  5. Incorrect SPL file name  Use the SPL document ID with the file extension .
  6. Not using the suffix element  Utilize the suffix element for any additional qualifiers (e.g. dosage form, route of administration, etc.) for proprietary names.

Additional notes:

  1. SPL Technical Q&A training sessions are held each Monday (except Federal holidays) from 11:30 a.m. - 12:00 - p.m., (Eastern Time Zone): Audio Conference details: Telephone number: 1-866-775-9435 - Participant pass code: 2219058
  2. Send SPL-related e-mails to the FDA SPL e-mail account: Do not send SPL-related e-mails to both and
  3. Test your SPL R4 documents via the Pragmatic Validator Lite tool to detect 90 - 95% of the technical errors which will be detected by FDA SPL R4 validation procedures:
  4. The HL7 SPL Working Group has provided a hyperlink to the SPL Release Four Common Errors training slides:
  5. The HL7 SPL Working Group's OTC sub team has provided a hyperlink to an OTC SPL document template: