OTC Drug Registration Process with FDA

The FDA registration process for OTC Monograph drugs includes several steps — from requesting a DUNS number to annual renewal. LMG assists foreign and domestic OTC drug manufacturers.

Step-by-Step GuideOTC Monograph DrugsDUNS RequiredSince 2009

FDA Registration Process for OTC Monograph 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), Anti dandruff shampoo 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 Monograph Drug Manufacturer

Step 1: Request a DUNS number for your establishment
Step 2: Register your drug establishment with FDA electronically
Step 3: Obtain an NDC Labeler Code
Step 4: List each OTC drug product with FDA in SPL format
Step 5: Upload Drug Facts labeling with the drug listing
Step 6: Renew registration annually October 1–December 31
Step 7: Update drug listings every June and December

FDA Registration Process for OTC Drug Labeler (Private Label Distributor)

Step 1: Request a DUNS number for your establishment
Step 2: Verify and confirm Manufacturer registration with FDA
Step 3: Obtain an NDC Labeler Code
Step 4: List each OTC drug product with FDA in SPL format
Step 5: Upload Drug Facts labeling with the drug listing
Step 6: Confirm Manufacturer registration annually October 1–December 31
Step 7: Update drug listings every June and December
If you feel the above steps are overwhelming or require more technical skills, please contact us. LMG can help you with all the above requirements.