NDC Labeller Code: What It Is, Why It Matters, and How It Works for OTC Companies

Daniel Jiménez
1 day ago
3 min read

For companies entering the U.S. over-the-counter (OTC) drug market, one of the first regulatory concepts that appears is the NDC Labeler Code.

Although widely referenced, it is also frequently misunderstood - particularly by international companies working under OEM or private label manufacturing models.

Understanding what the NDC Labeler Code is, who needs it, and how it interacts with other FDA identifiers is essential for successful market entry and compliance.

Why the Labeler Code Is Required for OTC Products

For OTC drugs marketed under FDA monographs, companies must:

Register their establishment with FDA
List their drug products electronically
Assign NDC numbers

The Labeler Code is the prerequisite for the listing process because it identifies the company submitting the product information to FDA databases.

Without a Labeler Code, a company cannot generate valid NDC numbers for its products.

Who Should Obtain the Labeler Code: Manufacturer or Brand Owner?

This is one of the most common questions in OEM and private label scenarios.

In FDA terminology, the “labeler” is the firm whose name appears on the product label as responsible for the product.

Therefore, the Labeler Code may belong to:

The brand owner (private label distributor)
The manufacturer
A repackager or relabeler

The determining factor is commercial responsibility, not physical manufacturing.

For many international companies using contract manufacturers, the brand owner typically obtains the Labeler Code because they market the product under their own name in the United States.

How It Works for Foreign Companies

Foreign companies can obtain a Labeler Code, but additional regulatory elements apply, such as appoint an U.S. Agent, who acts as the FDA’s primary domestic contact but does not own the Labeler Code unless the agent is also the labeler.

This distinction is important because some companies incorrectly assume the U.S. Agent holds regulatory ownership.

How Long Does It Take to Obtain a Labeler Code?

In practice, obtaining a Labeler Code may take several weeks, although planning should account for longer timelines when coordinated with full OTC registration activities.

NDC Labeler Code vs FEI Number vs DUNS Number

Another common source of confusion is the difference between FDA identifiers.

Identifier	Assigned By	What It Identifies	Purpose / Use	Key Notes
NDC Labeler Code	FDA	The company responsible for marketing the drug product	Used to create NDC numbers and list drug products in the FDA system	Required for OTC drug listing. Linked to the regulatory “labeler,” not necessarily the manufacturer.
FEI Number (FDA Establishment Identifier)	FDA	A physical facility (manufacturing, packaging, testing, etc.)	Used for establishment registration and FDA inspections	A company may have multiple FEI numbers if it operates multiple facilities.
DUNS Number (Dun & Bradstreet)	Private organization (Dun & Bradstreet)	A business entity globally	Used for company identification in regulatory and commercial systems, including FDA registrations	Supports identity verification but is not an FDA regulatory identifier itself.

The Role of the U.S. Agent

For foreign OTC companies, the U.S. Agent plays an important regulatory role but is frequently misunderstood.

The agent:

Serves as FDA’s communication contact in the United States
Facilitates interactions during inspections or regulatory questions
Supports administrative coordination

However, the U.S. Agent is not automatically responsible for product compliance and does not replace the regulatory responsibilities of the labeler.

Why Companies Often Need Regulatory Support

While the concept of a Labeller Code is simple, the regulatory context surrounding OTC products is significantly more complex.

Companies must align:

Establishment registration
Drug listing requirements
Monograph compliance
Labeling rules
Post-market obligations

For international companies, coordinating these elements across jurisdictions adds further complexity.

If your company is planning to commercialize OTC products in the United States or needs support with FDA registration, NDC assignment, or regulatory strategy, Belab Services can help.

Our specialists support international companies with: