Common Technical Errors in SPL R4 Submissions

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Common Technical Errors in SPL R4 Submissions


  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 Gateway’s “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:
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Topic Information
  • Topic #: 30026-1738
  • Date Created: 11/20/2012
  • Last Modified Since: 08/30/2016
  • Viewed: 1687
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