NDC & product identity

Structured Product Labeling (SPL)

Definition

The XML document standard in which manufacturers submit drug labeling to the FDA; it is the source of prescribing information shown in drug databases.

An SPL carries the full label — indications, dosage and administration, contraindications, warnings, adverse reactions — plus structured product data such as ingredients, packaging and codes. Each submission replaces the previous version.

Because SPL is the submission format rather than a curated database, its text is the manufacturer's own labeling verbatim, including inconsistencies of style and capitalisation.

openFDAThe FDA's public API, which exposes drug listing, labeling, adverse event and enforcement data as JSON.Definition NDC DirectoryThe FDA's published file of every drug currently or recently listed, updated daily and distributed through openFDA.Definition Boxed warningThe most serious warning the FDA requires on a drug label, set inside a black border.Definition

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Structured Product Labeling (SPL)

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