Structured Product Labeling (SPL) Terminology Files

The NCIt-SPL terminology files provided here support the cooperative efforts of the Food and Drug Administration (FDA) and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review of SPL Terminology Files data. The efforts are described more fully on the Structured Products Labeling web page.
Additionally, the FDA includes the Units of Measure data. More information can be found at: SPL Units of Measure

SPL terminology files are available for download from this NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/SPL/) in two formats:

FDA-SPL_NCIt_Subsets.xls
FDA-SPL_NCIt_Subsets.txt
SPL terminology is bundled into subsets, identified by code and name in the spreadsheet. These are the names and definitions of the subsets.

Subset Name Subset Description
FDA Structured Product Labeling Terminology Terminology used for representation of the information pertaining to blood form donor types in the framework of the SPL documents.
SPL Blood Form Donor Type Terminology Terminology used for representation of the information pertaining to blood form donor types in the framework of the SPL documents.
SPL Blood Form Establishment Functions Terminology Terminology used for representation of the information pertaining to blood form establishment functions in the framework of the SPL documents.
SPL Blood Form Establishment Type Terminology Terminology used for representation of the information pertaining to blood form establishment type in the framework of the SPL documents.
SPL Blood Form Product Type Terminology Terminology used for representation of the information pertaining to blood form product types in the framework of the SPL documents.
SPL Blood Form Type of Ownership Terminology Terminology used for representation of the information pertaining to blood form types of ownership in the framework of the SPL documents.
SPL Tissue Form Donor Type Terminology Terminology used for representation of the information pertaining to tissue form donor types in the framework of the SPL documents.
SPL Tissue Form Establishment Functions Terminology Terminology used for representation of the information pertaining to tissue form establishment functions in the framework of the SPL documents.
SPL Tissue Form Establishment Type Terminology Terminology used for representation of the information pertaining to tissue form establishment types in the framework of the SPL documents.
SPL Tissue Form Product Group Terminology Terminology used for representation of the information pertaining to tissue form product groups in the framework of the SPL documents.
SPL Tissue Form Product Type Terminology Terminology used for representation of the information pertaining to tissue form product types in the framework of the SPL documents.
SPL Business Operation Qualifier Terminology Terminology used for representation of the information pertaining to business operation qualifiers in the framework of the SPL documents.
SPL Business Entity Qualifier Terminology Terminology used for representation of the information pertaining to business entity qualifiers in the framework of the SPL documents.
SPL Color Terminology Terminology used for representation of the information on pharmaceutical product color in the framework of the SPL documents.
SPL Combination Product Type Terminology Terminology used for representation of the information pertaining to combination product types in the framework of the SPL documents.
SPL Contributing Factor-General Terminology Terminology used for representation of the information pertaining to contributing factors-general in the framework of the SPL documents.
SPL DEA Schedule Terminology Terminology used for representation of the information on the US Drug Enforcement Administration schedules of controlled substances in the framework of the SPL documents.
SPL Document Type Terminology Terminology that represents kinds of documents in supporting regulatory submissions in electronic format drug establishment registration and drug listing.
SPL Drug Route of Administration Terminology Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the SPL documents.
SPL Equivalence Codes Terminology Terminology used for representation of the information on equivalence codes in the framework of the SPL documents.
SPL Flavor Terminology Terminology used for the representation of the information on a pharmaceutical product the most predominant flavor in the framework of the SPL documents.
SPL License Disciplinary Action Terminology Terminology used for representation of the information on disciplinary action for license holders in the framework of the SPL documents.
SPL Licensing Terminology Terminology used for representation of the information on licensing in the framework of the SPL documents.
SPL Limitation Of Use Terminology Terminology used for representation of information on factors that could limit use of medical product for a specific indication in the framework of the SPL documentation.
SPL Lot Distribution Data - Distribution Codes Terminology Terminology used for representation of the information on lot distribution data in the framework of the SPL documents.
SPL Marketing Category Terminology Terminology used for representation of the information on pharmaceutical product marketing category in the framework of the SPL documents.
SPL Marketing Status Terminology Terminology used for representation of the information on pharmaceutical product marketing category status in the framework of the SPL documents.
SPL Miscellaneous Identifier Types Terminology Terminology used for representation of the information on miscellaneous identifier types in the framework of the SPL documents.
SPL Package Type Terminology Terminology used for representation of the information on pharmaceutical product package type in the framework of the SPL documents.
SPL Pharmaceutical Dosage Form Terminology Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.
SPL Pharmacokinetic Effect Consequences Terminology Terminology used for representation of information on consequences resulted from pharmacokinetic interactions between the drug and another drug or food in the framework of the SPL documentation.
SPL Race Terminology Terminology used for representation of the information on races in the framework of the SPL documents.
SPL REMS Protocol Terminology Terminology Terminology used for representation of the information on REMS protocols in the framework of the SPL documents.
SPL REMS Requirement Terminology Terminology Terminology used for representation of the information on REMS requirements in the framework of the SPL documents.
SPL REMS Stakeholder Terminology Terminology Terminology used for representation of the information on REMS stakeholders in the framework of the SPL documents.
SPL Sex Terminology Terminology used for representation of sex information in the framework of the SPL documents.
SPL Shape Terminology Terminology used for representation of the information on pharmaceutical product shape in the framework of the SPL documents.
SPL Substance Indexing Terminology Terminology used for representation of the information with substance indexing in the framework of the SPL documents.
SPL Suspect Drug Classification of Notification Terminology Terminology used for representation of the information on suspect drug classification in the framework of the SPL documents.
SPL Suspect Drug Use Terminology Terminology used for representation of the information on suspect drug use in the framework of the SPL documents.
SPL Type of Drug Interaction Consequence Terminology Terminology used to specify type of drug interaction consequence in the framework of the SPL documents.
SPL UCUM Terminology Terminology used for representation of the units of measurement in the framework of the SPL documents.
SPL Unit of Presentation Terminology Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format - drug establishment registration and drug listing.

Also included on the NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/SPL/) are the following additional files: About (This file)
Changes.txt (A text file of changes between the most recent and the current version of SPL terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.)
Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 11.02d which corresponds to the year 2011, the month of February, and the "d" refers to the fourth Monday of the month.)

N.B.: If there are no changes to the data for a particular month, the files will not be reposted. An update via the LISTSERV will be sent with this information. An NCI EVS SPL Data Terminology LISTSERV has been created for end users' questions and for update notifications. Please visit the following link to sign up for the LISTSERV and search for ncievs-spl-terms-L .

Archived files are available at: Archive/ Directory of dated release versions. Deprecated_FDA-SPL-NCIt_Subsets.xls contains SPL lists deprecated by the FDA.
Help requests on these files should go to NCIThesaurus@mail.nih.gov