Structured Product Labeling

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.

About SPL

Drug manufacturers and distributors submit documentation about their products to FDA. Labeling contains a summary of the essential scientific information needed for the safe and effective use of the drug. 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.

The openFDA drug product labeling API returns data from these submissions for both prescription and over-the-counter (OTC) drugs. The labeling is broken into sections, such as indications for use (prescription drugs) or purpose (OTC drugs), adverse reactions, and so forth. There is considerable variation between drug products, since the information required for safe and effective use varies with the unique characteristics of each drug product.

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General information
Learn more about Structured Product Labeling

Original dataset downloads
SPL download information

Provider

FDA

Updates

Frequency Weekly

Time period

Earliest data 2009