DATA STANDARDS MANUAL

FDA Data Element Number. DRG-0934

CDER Data Element Number. C-DRG-0934

Data Element Name. SPLFLAVOR

Data Element NCI ConceptID: C73338

Version Number: 2

Description. A characteristic of a dosage form of a medicinal product, specifying the most predominant flavor. SPLFLAVOR is not an FDA specification for the names of specific flavors that may appear as inactive ingredients in labeling.

Constraints. The observation value must be a single coded value, specifying one distinct flavor that approximates of the overall flavor of the dosage form.  SPLFLAVOR is selected from the list below. If more than one flavor exists, then the most predominant flavor is recorded.  If there is no predominant flavor, then choose one of the flavors to record.  Products that have more than one flavor packet included may record the overall flavor of each flavor packet.

Source. SPL

Relationship.

FDA Specifications. No further specifications.

CDER Specifications. No further specifications.

FDA Approved Date. March 14, 2008

CDER Approved Date. March 14, 2008

FDA Revised Date.  January 5, 2009

CDER Revised Date.  January 5, 2009

Data Values.

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