FDA Registration Process for OTC Drugs

FDA registration process for OTC Monograph drugs includes the below steps. Antiseptic hand sanitizer, Antiseptic Hand wash, Sunscreen, Acne cream, Pain Relief Cream (Menthol) etc. are examples of OTC Monograph drugs. The registration and listing requirements for manufacturer and private label distributor are not the same.

FDA registration process for OTC Drug Manufacturer

Step-1

Request DUNS number for your Establishment – FDA DUNS Lookup

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


FDA registration process for OTC Drug Labeler (Private Label Distributor)

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


If you believe the above steps are overwhelming or require more technical skills, please contact us. LMG can help you with all the above requirements.


Quick links

 

FDA Registration, US Agent, Labeler code USD 649 (Annually)
Drug listing USD 399 / Drug
Label Review USD 649 / Drug

Fees for other services

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