FDA Resources: SPL, Other Prescription Drug Labeling Resources, and Guidances

FDA's Structured Product Labeling Resources

Structured Product Labeling (SPL) is the standard format for electronic submission of the content of labeling. For SPL resources (including industry data standards for SPL), see FDA's SPL Resources page and the "Structured Product Labeling Resources" heading on FDA's Prescription Drug Labeling Resources page.

FDA's Prescription Drug Labeling Resources

This website provides over 100 labeling resources for the Prescribing Information, FDA-approved patient labeling, and/or carton and container labeling for human prescription drugs, including biological products.

FDA's Drug Guidances

Guidance documents represent the FDA's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method of obtaining guidance documents is through the Division of Drug Information.