Structured Product Labeling

$395 / year

The Structured Product Labeling dataset contains the most recent drug labeling information submitted to the Food and Drug Administration (FDA) and currently in use.
All labels information are published by DailyMed the official provider of FDA label information.

Complexity

The Structured Product Labeling dataset includes current drug labeling information like Product Name, Ingredients, Route of Administration, Package description and Indications approved by FDA for marketed products.
The regulations require that the content of labeling be submitted in a form that FDA can process, review, and archive.
Since 1999, FDA has been receiving the electronic content of labeling in Portable Document Format (PDF), and this format has allowed FDA to process, review
and archive the content of labeling.
FDA, working with other parties in HL7 (experts from HL7, industry, and technology solution providers), has adapted CDA for labeling in an HL7 standard called Structured Product Labeling (SPL). When compared with PDF, SPL exhibits the following advantages.
– SPL allows the exchange of information between computer systems in a way that cannot be accomplished with PDF. For example, the information in SPL can be used to support health information technology initiatives for improving patient care.
– The exchange of labeling changes with SPL can be easier and more efficient for both FDA and manufacturers when compared with PDF. For example, with SPL, only those sections or data elements of the labeling that are changed would need to be checked rather than the entire labeling.
– SPL allows automation of comparison of text by section and comparison of specific drug information data elements.
– SPL can also be used to exchange information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.

Date Created

2006-01

Last Modified

2018-10-18

Version

2018-10-09-08-07-06-19

Update Frequency

Monthly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => DailyMed, National Library of Medicine (NLM)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Structured Product Labeling, FDA Drug Labeling Information, Product Labeling, SPL, DailyMed

Other Titles

DailyMed Drugs Labeling, FDA Approved Drugs Labeling

Name Description Type Constraints
Product_NameThe Name of the productstring-
Product_TypeProduct type (Human/Animal, OTC/Prescription...)string-
IngredientsList of the ingredients of the productstring-
Route_Of_AdministrationRoute of Administration of the productstring-
Appearance_ShapeShape of the product (unit)string-
Appearance_SizeSize of the product (unit)string-
Appearance_ScoreProduct Characteristics: scorestring-
Package_DescriptionPackage Description of the productstring-
Dosage_FormDosage Form of the Productstring-
IndicationsIndications and Usage of the productstring-
ContraindicationsContraindications of the productstring-
Controlled_Substance_CodeControlled Substance Code in the product if includedstring-
Product_NameProduct_TypeIngredientsRoute_Of_AdministrationAppearance_ShapeAppearance_SizeAppearance_ScorePackage_DescriptionDosage_FormIndicationsContraindicationsControlled_Substance_Code
Indexing - product concept
Indexing - Product Concept
HUMAN PRESCRIPTION DRUGORAL
QCareHUMAN OTC DRUGORAL1 in 1 KIT
Human prescription drug labelORAL
Human Prescription Drug LabelORAL
HUMAN PRESCRIPTION DRUGINTRAVENOUS
Human prescription drug labelRECTAL
Human Prescription Drug LabelBUCCAL
Human Prescription Drug LabelTOPICAL