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Drug Establishment Registration

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States must register with the FDA. Domestic and foreign drug manufacturers, repackers, or re-labelers are also required to list all of their commercially marketed drug products. Drug products that are not correctly listed as required are misbranded and may be subject to regulatory action.
Foreign establishments that manufacture, repack, or re-label drug products and import or offer to import drug products to the United States must register with the FDA and identify a U.S. agent. All drugs imported into the United States must be listed by the foreign firm or its designated U.S. agent.
Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label distributors). Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

What is an OTC Drug Product?

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.

What is the FDA OTC Monograph?

The FDA OTC monograph is a ‘rule book’ for each therapeutic category containing information such as approved active ingredients, concentration limits, and labeling requirements under which an OTC drug is approved to be safe and effective. The FDA lists hundreds of FDA monographs within nearly 100 therapeutic areas. You can search the FDA OTC Monographs using keywords related to therapeutic category, ingredients, or dosage forms or check the comprehensive list of all FDA-proposed monographs, known as Historical Status of OTC Rulemakings, published on the official FDA website listed below: 1) FDA OTC Monograph Search Portal2) Historical Status of All OTC Rulemakings

Obtaining Labeler code

Labeler code, or NDC labeler code, is a 5-digit company identification number the FDA assigns to the manufacturer or distributor of OTC drugs. A labeler code is required to submit an OTC drug listing and obtain an NDC code. NDC code is a 10-digit identification number for all OTC drugs sold in the US that is also used for tracking, billing, and insurance purposes. Generally, the NDC labeler code is assigned only once to each company and typically does not expire.
Drug manufacturers must submit an electronic request in SPL format containing the company’s primary location, operation, and contact information to obtain the labeler code. Foreign entities must have a U.S. agent to submit a labeler code application. For more information, see What an NDC is and how it can be created.
A valid DUNS number is required before submitting a labeler code application; to obtain DUNS, see the list of DUNS regional offices and worldwide partners. When applying for a DUNS number for FDA registration, particularly for OTC drug registration, you must provide a valid physical address and complete the labeler code procedure. A virtual address, such as a mailbox address, is not acceptable.

Drug Establishment Registration Process Cost: $594

  • 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 collect additional company details
  • Step 3
    We prepare a draft for your review and approval
  • Step 4
    Drug Establishment Registration & Labeler Code Request, Drug Listing SPL Validation & FDA Submission
  • Step 5
    Your drug establishment will be officially registered with the FDA on the  Drug Establishment Current Registration Site (DECRS)
A Few Important Things To Note: - Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA. No additional fees required for U.S. Agent services. - Registration is required within five days of introducing drugs into commercial distribution. - There are no charges from the U.S. FDA for registration, so we can keep our fees low, at just $594. It takes approximately four to five working days to complete establishment registration. We also offer discounts for multiple facility registration. - FEI Services not included. We offer FEI Services as a stand-alone service for $119 (see form at the bottom of this page) - The FDA requires foreign facilities to provide a D-U-N-S Number for registration. If you don’t have one, we can assist in obtaining it for an additional fee. - Drug establishment registration and FDA approval are two different aspects; registration is one of the mandatory requirements for manufacturing, testing, process, and packing facilities. However, FDA approval is required before a drug can be imported into the US.

Drug Establishment Registration Form

Include suffix e.g, LLC, Limited, Inc, Pte Ltd, Pvt Ltd, etc.
This should be the facility address where the products are manufactured, packed, processed, or stored.
You will receive a receipt code to this email to confirm registration. Please provide the correct email address.
Include Country Code
Type(s) of Business Operation(s) - check all that apply
Registration Type
If you don't have a DUNS, we can help. Type 'No DUNS' in the field.
If you don't have an FEI, we can help. Type 'No FEI' in the field.
If you are using FDA Agent Pro as a US agent, leave the below information blank.
I want to appoint FDA Agent Pro as a US agent for drug establishment registration (Applicable to Foreign Outside USA Clients Only)
I Agree With The Terms and Conditions and Scope of Services Below
Drug Establishment FDA Registration Terms and Conditions / Scope of Services

OTC Drug Labeling Requirement

FDA neither reviews nor does pre-approve the label of the OTC drug products. Instead, it is the responsibility of the OTC drug manufacturer or distributor to comply with FDA OTC drug labeling requirements published by the FDA. A drug’s ‘intended use’ is critical in determining which FDA regulations will apply to its labeling. Claims that exceed the designated FDA category can push the drug into an unapproved category, risking FDA enforcement actions. Therefore, developing compliant content is crucial when designing a new drug label.
The OTC drug label must comply with a specific standardized format and content requirements for the OTC Drug Fact Panel (DFP) and Principal Display Panel (PDP) sections.

OTC Drug Listing

As a final step, 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.

FEI Number Application Form Cost: $119

Include suffix e.g, LLC, Limited, Inc, Pte Ltd, Pvt Ltd, etc.
Please provide the exact facility address, this address should match with food facility registration records. You must have proof of address, such as a government issued license.
Are you representing the firm as an Agent (third party)?
You will receive a receipt code to this email with confirmation. Please provide the correct email address.
Include Country Code
Select Operations Conducted At This Facility
If applicable
If applicable
(e.g., drug manufacturing, food packaging, etc.)
I Agree With The Terms and Conditions and Scope of Services Below
FDA Establishment Identifier (FEI) Terms and Conditions / Scope of Services