Depending on the Document Type being created, Labeler, Registrant, Establishment US Agent and Import information can be added to the SPL file.

See FDA SPL Online Resources for more information under:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

	Labeler	Labeler information and all its dependent company data such as registrant, manufacturer, us agent etc.
	Company Name	Company name of the labeling firm
	DUNS Number	Labeler Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
	NDC Labeler Code	National Drug Code Directory - code of the labeling company - check http://www.fda.gov for details
	Labeler Contact	Labeler contact information
	Registrant	Registration holder company and contact information

	Labeler Contact	Labeler contact information
	Address	Street name and -number
	City
	State	US State if applicable, else to be removed
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code
	Phone
	Email
	Contact Person Name

	Registrant	Registration holder company and contact information
	Company Name	Company name of the registration holder
	DUNS Number	Registration holder Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
	Confidentiality	B=Business Confidentiality - if not confidential then remove information
	Registrant Contact	Registration holder contact
	Establishment	Establishment information of company involved in the marketing process

	Registrant Contact	Registration holder contact
	Address	Street name and -number
	City
	State	US State if applicable, else to be removed
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code
	Phone
	Email
	Contact Person Name

	Establishment	Establishment information of company involved in the marketing process
	Company Name	Company name of the establishment involved in the marketing process
	DUNS Number	Establishment Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
	FDA Establishment Identifier	FDA Establishment Identifier - check http://www.fda.gov for details
	Confidentiality	B=Business Confidentiality - if not confidential then remove information
	Business Operation Code	UNII Code for Establishment Business Operation, select from list or use FDA provided values
	Business Operation Display Name	UNII Display Name for Business Operation, Establishment Business Operation, select from list or use FDA provided values
	Establishment Address	Address of the establishment involved in the marketing process
	Establishment Contact	Contact details of the establishment involved in the marketing process
	US Agent	US Agent involved in the marketing process
	Importer	Company information which is importing to the USA

	Establishment Address	Address of the establishment involved in the marketing process
	Address	Street name and -number
	City
	State	US State if applicable, else to be removed
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code of the Establishment

	Establishment Contact	Contact details of the establishment involved in the marketing process
	Address	Street name and -number
	City
	State	US State if applicable, else to be removed
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code the Establishment Contact
	Phone
	Email
	Contact Person Name

	US Agent	US Agent involved in the marketing process
	Company Name	Company name of the US agent involved in the marketing process
	DUNS Number	US agent Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
	Address	Street name and -number
	City
	State	US State
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code
	Phone
	Email

	Importer	Company information which is importing to the USA
	Company Name	Company name of the Importing firm involved in the marketing process
	DUNS Number	Importing firm Dun and Bradstreet Number - check http://www.dnb.com/us/ for details
	Address
	City
	State	US State
	Postal Code
	Country	ISO 3166-1 Alpha-3 Country Code of the Importing firm
	Phone
	Email

(c) sartori-software.com 2018