2008AB FDA Structured Product Labels Source Information

Web site:
http://www.fda.gov/oc/datacouncil/SPL.html

Authority
The U.S. National Library of Medicine (NLM) produces the Metathesaurus FDA Structured Product Labels (MTHSPL), which is based on the Food and Drug Administration (FDA) Structured Product Labeling (SPL). Information for this source is extracted from the NLM DailyMed Web site.

Purpose
Concept names with this source abbreviation were created by NLM to provide contextual information for FDA SPL terms.

SPL is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA as a mechanism for exchanging medication information.

Metathesaurus Scope
MTHSPL includes drug product and active substance terminology used in Structured Product Labels.

MTHSPL contains approximately 9,000 drug products and 2,000 substances.

Metathesaurus Update Frequency
MTHSPL is updated in each Metathesaurus release as part of RxNorm.

Additional Information
Drug labels and the most recently updated information are available on DailyMed. Health information suppliers can download drug labels in SPL format from DailyMed. Drug labeling on DailyMed is the most recent submitted to the FDA and currently in use.

Sites Consulted

1. FDA Standards Data Council. Rockville (MD): Food and Drug Administration (US). Facts@FDA; [cited 2008 Oct 01]. Available from: http://www.fda.gov/oc/datacouncil/drug_labels.htm
2. FDA Standards Data Council. Rockville (MD): Food and Drug Administration (US). Structured product labeling resources; [cited 2008 Oct 01]. Available from: http://www.fda.gov/oc/datacouncil/SPL.html