Over-The-Counter (OTC) Drug Listing
- The FDA considers Over-the-counter (OTC) drugs safe and effective, yet they can be purchased without a prescription. Over 300,000 OTC drugs exist within about 100 different therapeutic categories in the US market. Some examples of OTC drug products are acne creams, dry-eye drops, sunscreen, sanitizers, etc. To enter the US market, all OTC products must follow and comply with specific FDA pre-approved OTC drug formulation rules, known as FDA monographs.
- Any OTC drug produced outside the FDA monograph system is labeled as an “Unapproved Drug.” This includes OTC products marketed without formal FDA approval, which indicates they have not undergone FDA review for safety, effectiveness, and proper labeling. Examples include some “unapproved Homeopathic” remedies and “unapproved Animal” medications.
More about OTC Drug Listing
The OTC drug manufacturer and distributor must list the drug, submit the product’s label to the FDA, and obtain a 10-digit NDC code. The submission must contain all important information about the drug, such as active and inactive ingredients, inner and outer packaging, container type, FDA monograph number or citation, marketing start and end dates, drug facts panel information, etc. The OTC drug listing form must be submitted electronically using SPL format.
Once an OTC drug listing is complete, the registrant will receive the OTC drug NDC number. The drug registration record will be published in the FDA NDC directory within a few days after submission. All OTC drug listings must be renewed or certified annually between October 1 and December 31.
Once an OTC drug listing is complete, the registrant will receive the OTC drug NDC number. The drug registration record will be published in the FDA NDC directory within a few days after submission. All OTC drug listings must be renewed or certified annually between October 1 and December 31.
OTC Drug Listing Process Cost: $494
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to verify facility DUNS/FEI, Drug Category and other details
Step 3
We prepare a draft for your review and approval, then submit the drug establishment registration and labeler code request
Step 4
Drug Listing SPL validation & FDA submission, official NDC Publication by FDA & certificate issued by us