The FDA requires drug labeling to be submitted in Structured Product Labeling (SPL) format, an XML-based standard used for drug product labels, package inserts, and medication guides. Accurate SPL submissions are essential for drug listing and product approval. We prepare and submit SPL files on your behalf.
Prescription Drug SPL
Prescription drug labels and package inserts (Prescribing Information) must be submitted in SPL format via the FDA’s Electronic Submissions Gateway (ESG).
- Full prescribing information (PI) SPL
- Medication guide SPL preparation
- Patient package insert (PPI) SPL
- ESG submission coordination
OTC Drug SPL
Over-the-counter drug products require SPL submissions for their Drug Facts label content. We prepare accurate OTC SPL files for DRLS submission.
- Drug Facts label SPL preparation
- Active ingredient & dosage SPL
- Indications & warnings SPL
- DRLS system submission
SPL Updates & Amendments
When drug labeling changes, such as new warnings, updated indications, or reformulations, SPL files must be updated and resubmitted to the FDA promptly.
- Safety update SPL amendments
- Labeling revision resubmissions
- Version tracking & management
- FDA correspondence support
Establishment SPL
Drug establishment registrations and drug listings submitted also use SPL format. We prepare establishment SPL files as part of our registration services.
- Establishment registration SPL
- Drug listing SPL preparation
- NDC labeler code SPL submissions
- Annual update coordination
Start Your Structured Product Labeling
A rejected or late SPL submission can delay your product’s listing and market access. Let us prepare and file it correctly the first time.
Structured Product Labeling FAQs
SPL is an XML-based format the FDA requires for submitting drug labeling content, including prescribing information, medication guides, Drug Facts labels, and establishment registration and listing data.
Yes. Prescription drugs submit prescribing information and medication guides in SPL format, while OTC drugs submit their Drug Facts label content in SPL format. Both are transmitted through the FDA’s Electronic Submissions Gateway (ESG).
Anytime labeling changes, such as a new warning, an updated indication, or a reformulation, the SPL file must be updated and resubmitted to the FDA promptly to keep your listing accurate.
Yes. We manage SPL preparation and resubmission for existing products, including safety updates, labeling revisions, and annual establishment and listing updates.