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12. Product Identity	12. Product Identity
Product Identity (32)	Structured Product Label (1)
description:	Ontomatica's Structured Product Label Application integrates relevant ontology rules (items, properties, relationships and constraints) with relevant data sets. The Structured Product Label Application is the electronic specification of a medicinal product following the FDA structured product labeling (SPL) standard. Background: Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. The "drug label" includes all published material accompanying a drug, such as the actual label on a prescribed dose as well as the package insert which contains a great deal of detailed information about the drug. As of Release 4 of the SPL standard, 22,000 FDA informational product inserts have been encoded according to the standard. SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).