FDA Approval for Hand sanitizer



Hand sanitizers complying with FDA OTC Monograph does not require FDA Approval. FDA Approval (NDA or ANDA) is required for antiseptic hand sanitizer which does not complying with OTC Monograph.


Eligible Hand sanitizer active ingredients in FDA OTC Monograph


Benzalkonium chloride, Ethyl alcohol or Ethanol ( 60 to 95 percent) and Isopropyl alcohol (70 to 91.3 percent) are the only eligible active ingredients in OTC Monograph.


FDA Regulations for Hand Sanitizer Manufacturer


Even though the Hand sanitizer manufacturer follow the OTC Monograph, they have to comply with all other drug manufacturer requirements like


  • FDA Registration
  • NDC Number
  • Hand sanitizer listing
  • Hand sanitizer labeling compliance
  • GMP – Good Manufacturing Practice


NDC Number for Hand Sanitizer


Each hand sanitizer must have a unique NDC number. if the difference is only in the package size the last segment of NDC number must be different. If the ingredient, proprietary name, intended use etc are different, a new NDC number must be assigned and separate drug listing is required.


Hand sanitizer Establishment registration and NDC Number request form

Hand sanitizer listing form

Fees for FDA registration and listing