Selection of Appropriate SPL Codes for Human Prescription Drug Labeling

This supplementary webpage is primarily directed to Structured Product Labeling (SPL) developers to assist in selection of appropriate SPL codes for human prescription drug* labeling.  See the main SPL resources webpage for additional SPL resources (e.g., guidances implementation guides and validation procedures, style sheets) and the Electronic Drug Registration and Listing Instructions webpage for instructions on how to register an establishment and list a drug with the FDA. For more information about:

• Other prescription drug labeling resources for industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs.
• Drug labeling resources for healthcare professionals, patients, and caregivers, visit Frequently Asked Questions about Labeling for Prescription Medicines.

SPL is standard format for the electronic submission of the content of labeling:

• Prescribing Information (PI) and
• FDA-approved patient labeling [e.g., Medication Guides (MG), Patient Package Inserts (PPI), and Instructions for Use (IFU)]. 

When creating SPL, FDA encourages application holders to select the most specific, appropriate Logical Observation Identifiers Names and Codes (LOINC) to allow SPL users to identify content within each section and subsection of the PI and to identify content in different types of prescription drug labeling (e.g., PI, MG, PPI, IFU, or carton/container labeling).  For additional information on the rationale for appropriate selection of LOINC names and codes for human prescription drug labeling see Improving the Accuracy of SPL Submissions – The Missing LOINC (2019 presentation and video).

SPL Prescription Drug Labeling Guidances

• Indexing Structured Product Labeling (final guidance)
• Providing Regulatory Submissions in Electronic Format - Content of Labeling (final guidance)
• Public Availability of Labeling Changes in “Changes Being Effected” Supplements (draft guidance)
• SPL Standard for Content of Labeling Technical Questions and Answers (draft guidance)

Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.