Domains

clinical, drug discovery, pharmacology, public health

License

Warning: No license entered

Homepage

unii

Repository

ginas.ncats.nih.gov

Infores ID

infores:unii

FAIRsharing ID

Unknown

Product Summary

Contacts

FDA Substance Registration System Team

Email: FDA-SRS@fda.hhs.gov

Publications

FDA Grand Rounds: FDA's Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs)

Products

From this Resource

ID	Name	URL	Category	Format	Description
unii.search	UNII Search Service	uniisearch	GraphicalInterface	http	Web-based search interface for findin...
unii.list ⚠	UNII List Download	UNIIs.zip	Product	csv	Downloadable list of all UNIIs with b...
unii.data ⚠	UNII Data Download	UNII_Data.zip	Product	mixed	Comprehensive UNII data with detailed...
unii.legacy ⚠	Legacy UNIIs	Legacy_UNIIs.txt	Product	txt	Legacy UNII identifiers for historica...

From other Resources

ID	Name	URL	Category	Format	Description
mechreponet.kg	MechRepoNet Knowledge Graph	publication		❔	The MechRepoNet knowledge graph in it...

Relevant Taxa

Human (NCBITaxon:9606)

Details

FDA Global Substance Registration System (UNII)

The FDA’s Global Substance Registration System (GSRS) is a comprehensive, authoritative database that generates Unique Ingredient Identifiers (UNIIs) for substances in FDA-regulated products. Developed through collaboration between the FDA’s Informatics team, NIH’s National Center for Advancing Translational Sciences (NCATS), and the European Medicines Agency (EMA), GSRS addresses the critical need for accurate substance identification across global regulatory domains.

Overview

UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements, providing standardized identifiers that transcend the variability of substance names across different regulatory domains, countries, and regions. The system classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture as detailed in ISO 11238 and ISO DTS 19844 standards.

Key Features

Comprehensive Coverage: UNIIs can be generated for any substance at any time in the regulatory life cycle, from atoms to organisms
Global Standardization: Enables efficient and accurate exchange of substance information across regulatory domains
Scientific Classification: Substances are defined by standardized, scientific descriptions rather than variable names
Regulatory Integration: Used in electronic listing systems like DailyMed and throughout product life cycles including clinical trials, marketing, and post-market surveillance

Products and Access

The GSRS provides multiple ways to access UNII data:

UNII Search Service: Interactive web interface for searching substances by UNII, name, or other identifiers
Downloadable Data: Comprehensive datasets including UNII lists and detailed substance data
Public GSRS Interface: Full access to the Global Substance Registration System hosted by NCATS
PrecisionFDA Integration: Collaborative tools for filtering, exporting, and creating GSRS records

Applications

UNII identifiers are essential for:

Drug labeling and electronic submissions
Clinical trial identification
Product safety monitoring
Global supply chain tracking
Regulatory compliance across FDA-regulated products (food, drugs, tobacco, cosmetics)

Data Quality and Updates

The system is regularly updated, with the most recent data refresh on August 18, 2025. UNIIs are generated based on the best available public information, and synonyms and mappings are continuously refined. The FDA encourages reporting of data issues to maintain accuracy and completeness.