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  1. FDA Data Standards Advisory Board

Structured Product Labeling Resources

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.


SPL Guidance Documents

SPL Implementation Guide and Validation Procedures

GDUFA SPL Step-by-Step Instructions & Technical Specifications
SPL Dockets

SPL Schema and Stylesheet

Download Labeling

  • FDALabel: FDA’s web-based application designed to perform customizable searches of over 140,000 labeling for human prescription drug; nonprescription drugs; and labeling for other products (e.g., animal nonprescription and animal prescription drugs, cosmetics, dietary supplements, medical devices, medical foods). FDALabel and DailyMed have the same database but have different search functions and different displays of search results.
  • FDA Online Label Repository


SPL Terminology

SPL Terminology Files for Validation
Terminology for Indexing SPL

Contact Information

Questions regarding SPL submissions should be directed to: spl@fda.hhs.gov.

Resources For You

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