Every prescription drug (including biological drug products) approved by FDA for human use comes with FDA-approved labeling. The openFDA drug product labeling API provides data for prescription and over-the-counter (OTC) drug labeling. Since mid-2009, labeling has been posted publicly in the Structured Product Labeling (SPL) format.
The openFDA drug product labeling API returns data from the FDA Structured Product Labeling (SPL) dataset. This dataset contains structured documentation about regulated products, submitted by manufacturers to FDA. OpenFDA uses the latest available bulk downloads, which have the latest version of every structured product labeling document for products that are actively marketed.