How can FDAbasics help you ? What is the time and cost? 

We offer below services to comply with FDA requirements for Hand Sanitizers.

  1. US Agent services– Appointment of US Agent is mandatory for foreign companies. Our fee for US Agent services is $ 299 per year. You can complete an  online form at the link below and make the payment.  After receipt of the completed form and the payment, we shall email US Agent details and DUNS number.   
  2.  Labeler code approval  – We can assist you to  obtain a labeler code from FDA. Labeler code is a 5 digit code assigned by FDA which is  required to assign the NDC number  your product.  Our fee for  the labeler code application is $ 399.   It will take about  2 business days to obtain a labeler code .
  3. OTC  Drug  Labeling review – Labeling compliance is one of important requirements for OTC drugs. We can assist you to comply with labeling requirements, our fee for labeling review is $ 399 per product.
  4. NDC Drug Listing  –  We will prepare and submit the drug listing on behalf of you, our fee is $  399 per product.
  5.  Drug Establishment Registration – Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Our fee for drug establishment registration is $ 299.

Please contact us for information .


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