FDA Registration Process for OTC Monograph Drugs

Step-1

Request DUNS number for your Establishment – FDA DUNS Request

Step-2

Register the Manufacturing Establishment with FDA – FDA Registration Form

Step-3

Request NDC labeler code to FDA – NDC Labeler Code Request Form

Step-4

Re-submit the NDC labeler code request SPL to FDA

Step-5

Submit Drug listing SPL to FDA – Drug Listing Form

Step-1

Request DUNS number for your Establishment.

Step-2

Verify and confirm Manufacturer registration with FDA – Verify FDA registration

Step-3

Request NDC labeler code to FDA – NDC Labeler code Assignment

Step-4

Re-submit the NDC labeler code request SPL to FDA

Step-5

Submit Drug listing SPL to FDA – Verify Drug listing

• Hand Sanitizer Import Requirements
• Hand Sanitizer Regulations - US FDA
• FDA Registration Certificate
• U.S. FDA Agent Requirements
• FDA Agent Services
• Food Registration - FAQ
• FDA Registration & US Agent Fees
• FDA Detention of Products
• Dietary Supplement Registration

• Hand Sanitizer - FDA final rule
• OTC Drug Establishment Registration
• Drug Establishment Registration
• Compounding pharmacy registration
• NDC Labeler code
• NDC SPL File Submission
• OTC-Monograph
• Homeopathic Registration
• API Drug Registration