Hand Sanitizer FDA OTC Registration NDC Number

Disinfectants, hand sanitizers, disinfecting wipes, etc., used for medical purposes or for disinfecting human hands, are regulated by the FDA. Those used for disinfecting hard surfaces or other purposes fall under the jurisdiction of the EPA.

Definition of OTC
The FDA defines over-the-counter (OTC) drugs as safe and effective for public use without a doctor's prescription. Products such as hand sanitizers, disinfectants, antiseptic hand washes, spray disinfectants, disinfecting wipes, antiseptic cotton, burn ointments, and hair growth solutions are all classified as OTC.
If intended for human use, they are regulated by the FDA; if used for environmental or object disinfection, they fall under EPA oversight.
Some products may be both OTC and cosmetics. Examples include fluoride toothpaste, deodorants that also function as antiperspirants, and moisturizers and cosmetics marketed with sun protection claims.
Terminology Explanation
Labeler Code: The manufacturer code assigned by the FDA after application submission, typically a 5-digit number, e.g., 71234.
NDC: National Drug Code, the unique identifier for drugs in the United States.
Product NDC: The NDC number for a product, usually 7 or 8 digits, e.g., 71234-001 or 71234-01. Generally, products with the same formulation share the same Product NDC, while different formulations have different codes.
NDC Package Code: The NDC number for the packaging, typically a 10-digit number, e.g., 71234-001-01 or 71234-01-001.
Generally, for the same formulation with different packaging sizes, the first 7 or 8 digits remain the same, while the last 2 or 3 digits differ.
Package Description: A description of the packaging specifications, e.g., 50mL in 1 Bottle (hand sanitizer), 20g in 1 Tube (ointment), 30 Cloths in 1 bag (disinfecting wipes).
After registration, products must comply with FDA OTC labeling requirements to be legally sold.
Additionally, the registered NDC Package Code must be displayed on the product packaging.
If there is a designated U.S. importer, it must be added to the company’s registration information (requiring: importer name, D-U-N-S number, email, phone number).
The FDA may conduct random inspections of OTC drug manufacturers. Companies selected for inspection must undergo a facility audit based on the standards of 21 CFR PART 210, commonly referred to as cGMP.