Most new manufacturers of OTC drugs like sunscreen, hand sanitizer etc... are confused of how to assign NDC Number for their drug,

• Whether FDA will assign 10 digit labeler code for each drug?
• Do the manufacturer need to send product sample to FDA for registration?
• Do the manufacturer / labeler need to send the drug label hard copy to FDA?, etc...

FDA will assign only the first part of (first 4 or 5 digits) 10 digit NDC number, the labeler need to assign the remaining 5 or 6 digits. The manufacturer does not need to send product sample or label for registration.

For more information about NDC number / Labeler code assignment or to request an NDC labeler code for your establishment please contact us at info@fdahelp.us

Examples of labeler code assigned by different manufacturers for different products are given below.