Drug DUNS Number
Request Assistance
The FDA requires all drug establishments and labelers to obtain a valid DUNS Number as part of Drug Establishment Registration and drug listing compliance. Without a DUNS Number, your FDA registration may be cancelled and drug listing delayed. FDA Registration Assistance manages the complete DUNS request process — verifying your facility information and ensuring your DUNS Number meets all FDA requirements.
What Is a DUNS Number & Why Does the FDA Require It?
A DUNS Number (Data Universal Numbering System) is a 9-digit unique identifier issued by Dun & Bradstreet (D&B) that the FDA uses to identify the physical location of drug establishments and labelers. The FDA has required DUNS Numbers for drug establishment registration since 2009, and failure to obtain or properly list a DUNS Number may result in cancellation of your FDA Drug Establishment Registration.
FDA Registration Assistance manages the complete DUNS Number request process on your behalf — verifying your facility name and address against Dun & Bradstreet records, submitting the DUNS application, and confirming your number is correctly linked to your FDA Drug Establishment Registration and drug listings.
- Required for all drug establishments and labelers registering with the FDA
- Each physical facility address requires its own unique DUNS Number
- Failure to obtain a DUNS Number may result in FDA Drug Establishment Registration cancellation
- DUNS Number must accurately match the facility name and address on file with the FDA
Drug DUNS Number Request & Verification Services
Everything drug establishments and labelers need to obtain their DUNS Number correctly and stay fully FDA-compliant.
DUNS Application Assistance
FDA Registration Assistance manages the complete DUNS Number application process on your behalf — preparing and submitting your request to Dun & Bradstreet with accurate facility name, address, and business information to ensure a smooth, timely assignment.
Facility Name & Address Verification
The FDA verifies all drug establishment information against Dun & Bradstreet records. FDA Registration Assistance confirms your facility name and address are accurately matched — preventing registration mismatches that could delay or cancel your FDA Drug Establishment Registration.
FDA Registration Coordination
FDA Registration Assistance coordinates your DUNS Number with your FDA Drug Establishment Registration and drug listing submissions — ensuring your DUNS Number is correctly listed across all required FDA filings and fully meets FDA compliance requirements.
Ongoing Compliance Support
FDA Registration Assistance provides ongoing support to ensure your DUNS Number remains current and accurately reflected in your FDA registrations — including assistance with updates whenever your facility name, address, or business information changes.
Trusted FDA Drug DUNS Number & Registration Compliance Partner
Helping drug establishments and labelers obtain their DUNS Numbers correctly — ensuring FDA Drug Establishment Registration compliance from day one.
How Our Drug DUNS Request Service Works
A simple four-step process to obtain your DUNS Number and ensure full FDA Drug Establishment Registration compliance.
Submit Facility Information
Provide your facility's legal name, physical address, and business details. FDA Registration Assistance reviews your information to ensure it is ready for accurate DUNS Number application and FDA verification.
DUNS Application Prepared & Submitted
FDA Registration Assistance prepares and submits your DUNS Number application to Dun & Bradstreet on your behalf — ensuring all facility information is accurate and matches what the FDA requires for drug establishment registration.
DUNS Number Assigned & Verified
Once assigned, FDA Registration Assistance verifies your DUNS Number and confirms it accurately reflects your facility information — ensuring it is ready for use in your FDA Drug Establishment Registration and drug listing submissions.
FDA Registration Compliance Confirmed
FDA Registration Assistance confirms your DUNS Number is correctly listed across all required FDA filings — ensuring your Drug Establishment Registration remains active and your facility stays fully FDA-compliant.
Complete FDA Drug Registration Solutions
We offer a full range of FDA registration and compliance services to help your facility and shipments meet all U.S. regulatory requirements.
Drug Establishment Registration
Register your foreign or domestic drug manufacturing, repacking, or relabeling facility with the FDA — required for all drug products distributed in the U.S.
Labeler Code Registration
Obtain your FDA Labeler Code — required to identify your company on drug product labels and NDC numbers distributed in the United States.
NDC Code / Product Code
Register your National Drug Code (NDC) and product codes with the FDA — mandatory for all drug products commercially distributed in the U.S.
Drug Label & Ingredient Review
Ensure your drug product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
DUNS Request Assistance
Obtain your DUNS Number required for FDA Drug Establishment Registration and federal compliance — filed accurately on your behalf.
Drug / OTC U.S. Agent Services
Designate a U.S. FDA Agent for your foreign drug establishment — legally required for all foreign drug facilities registered with the FDA.
FDA Drug Listing Certificate
Obtain your official FDA Drug Listing Certificate confirming your drug product is registered and listed with the U.S. Food and Drug Administration.
FDA Drug Master Files (DMF)
Submit an FDA Drug Master File (DMF) to protect confidential manufacturing information while supporting drug product applications and registrations.
Drug Import Alert Removal
Get expert help resolving FDA drug import alerts and detentions to restore your drug products' ability to enter the United States.
Frequently Asked Questions About Drug DUNS Request Assistance
Find answers to the most common questions about FDA DUNS Number requirements for drug establishments and how FDA Registration Assistance helps you obtain and verify your DUNS Number correctly.
What is a DUNS Number and why does the FDA require it?
A DUNS Number (Data Universal Numbering System) is a 9-digit unique identifier issued by Dun & Bradstreet that the FDA uses to identify and verify the physical location of drug establishments and labelers. The FDA has required DUNS Numbers for drug establishment registration since 2009. FDA Registration Assistance manages the complete DUNS request process to ensure your number is obtained correctly and meets all FDA requirements.
Who is required to have a DUNS Number for FDA registration?
All drug establishments and drug labelers — including manufacturers, repackers, relabelers, and distributors of drug products intended for the U.S. market — are required to have a valid DUNS Number listed in their FDA Drug Establishment Registration. FDA Registration Assistance assists both domestic and foreign facilities in obtaining their DUNS Number correctly.
What happens if I do not obtain a DUNS Number?
Failure to obtain or properly list a DUNS Number in your FDA Drug Establishment Registration may result in cancellation of your registration, delays in drug listing, and increased regulatory risk or enforcement action. FDA Registration Assistance ensures your DUNS Number is obtained and correctly listed before any FDA registration deadline.
Does the DUNS Number replace my FDA Registration Number?
No. The DUNS Number does not replace your FDA Drug Establishment Registration Number. It is a separate identifier used by the FDA to verify the physical location of your facility. Both are required for full FDA Drug Establishment Registration compliance. FDA Registration Assistance assists with both your DUNS Number and your FDA Drug Establishment Registration.
Does each physical facility location need its own DUNS Number?
Yes. Each physical facility address requires its own unique DUNS Number. If your company operates drug manufacturing, repacking, or distribution activities at multiple locations, each address must have a separate DUNS Number. FDA Registration Assistance can assist with DUNS Number applications for multiple facility locations.
Can a foreign drug establishment obtain a DUNS Number?
Yes. Foreign drug establishments seeking to register with the FDA are also required to obtain a DUNS Number. FDA Registration Assistance has assisted companies in over 135 countries with their DUNS Number applications and FDA Drug Establishment Registration compliance.
How does FDA Registration Assistance obtain my DUNS Number?
FDA Registration Assistance prepares and submits your DUNS Number application to Dun & Bradstreet with your facility's accurate legal name, physical address, and business information. We verify all details before submission, confirm the assigned DUNS Number, and ensure it is correctly linked to your FDA Drug Establishment Registration.
What information is needed to apply for a DUNS Number?
To apply for a DUNS Number, FDA Registration Assistance requires your facility's legal business name, physical address, contact information, and principal business activity. FDA Registration Assistance verifies all information against Dun & Bradstreet records before submission to ensure accuracy and prevent mismatches with FDA records.
Why must my DUNS Number exactly match my FDA registration information?
The FDA cross-references your Drug Establishment Registration information with Dun & Bradstreet records. If your facility name or address does not exactly match your DUNS record, your registration may be rejected or cancelled. FDA Registration Assistance verifies your information is accurately matched before submission to prevent this issue.
Is a DUNS Number also required for Labeler Code registration?
Yes. A valid DUNS Number is required before the FDA will assign a Labeler Code. The FDA verifies your company information against Dun & Bradstreet records as part of the Labeler Code assignment process. FDA Registration Assistance can assist with both your DUNS Number application and your subsequent Labeler Code registration.
How long does it take to obtain a DUNS Number?
A DUNS Number can typically be obtained within a few business days when submitted correctly with accurate facility information. FDA Registration Assistance prepares and submits your application to minimize delays — ensuring your DUNS Number is available in time for your FDA Drug Establishment Registration filing.
How much does DUNS Request Assistance cost through FDA Registration Assistance?
FDA Registration Assistance charges a one-time fee of $399 USD for the complete Drug DUNS Request Assistance service — including DUNS application preparation, submission to Dun & Bradstreet, verification, and coordination with your FDA Drug Establishment Registration. Contact FDA Registration Assistance today to get started.
Does my DUNS Number need to be updated if my facility information changes?
Yes. If your facility name, address, or other DUNS-listed information changes, your DUNS record must be updated to match your current FDA registration information. FDA Registration Assistance provides ongoing support to keep your DUNS Number current and accurately reflected in all FDA filings.
Can FDA Registration Assistance help if my registration was cancelled due to a missing DUNS Number?
Yes. FDA Registration Assistance can assist with obtaining your DUNS Number and re-establishing your FDA Drug Establishment Registration if it was cancelled due to a missing or incorrect DUNS Number. Contact FDA Registration Assistance as soon as possible to resolve the issue and restore your registration compliance.
Is a DUNS Number required for drug listing submissions?
Yes. A valid DUNS Number is required not only for FDA Drug Establishment Registration but also for drug listing submissions. FDA Registration Assistance ensures your DUNS Number is correctly obtained and listed in all required FDA filings — including drug establishment registration and drug listing submissions.
Can FDA Registration Assistance assist with both my DUNS Number and my full FDA Drug Establishment Registration?
Yes. FDA Registration Assistance provides a full range of FDA drug compliance services — including DUNS Number assistance, Drug Establishment Registration, Labeler Code Assignment, NDC Code Registration, Drug Label Review, and ongoing compliance support. Contact FDA Registration Assistance to discuss your complete FDA registration needs.
Get Your DUNS Number Today
Submit your facility details and FDA Registration Assistance will manage the complete DUNS Number application process — verifying your information, submitting to Dun & Bradstreet, and ensuring your DUNS Number is correctly linked to your FDA Drug Establishment Registration.
Thank You for Reaching Out!
We've received your message and will get back to you within 24 hours. If you need immediate assistance, please call us directly.