The short answer
Every drug sold in the U.S. — including over-the-counter (OTC) products such as sunscreens, hand sanitizers, pain relievers and antiseptic creams — must be listed with FDA and carry a National Drug Code (NDC). The NDC has three parts: a labeler code (who), a product code (what) and a package code (pack size and type).
A foreign brand owner that does not make the product can still have its own labeler code, as a private label distributor. The manufacturer must be registered with FDA and lists the product using the brand owner’s labeler code. An NDC is an identifier, not an approval.
| Who | What they need |
|---|---|
| Manufacturing site (in any country) | FDA drug establishment registration (with a U.S. Agent if foreign), its own labeler code, cGMP compliance |
| Brand owner that does not manufacture (private label distributor) | Its own labeler code, if it wants its own NDCs on its brand |
| Each product and pack size | A drug listing with an NDC, submitted electronically in SPL format |
How the NDC works today
Today the NDC is usually 10 digits, in one of three layouts (4-4-2, 5-3-2 or 5-4-1). FDA assigns the labeler code; the firm proposes the product and package codes, and FDA assigns the NDC when it receives the listing.
- Who must get a labeler code: anyone who manufactures, repacks, relabels or private-label distributes a listed drug (21 CFR 207.33).
- How to ask: submit a labeler code request in SPL format with the company name, its D-U-N-S number and a contact person. Once FDA assigns the code, submit an updated SPL with the code filled in — only then can products be listed under it.
- Keep it active: FDA says labeler codes with no drug listings may be deactivated after two years, and changes must be updated within 30 days.
- Who should not apply: FDA says a company that does not manufacture or distribute drugs in the U.S. should not apply for a labeler code.
The NDC is changing to 12 digits — in 2033
FDA’s final rule of March 5, 2026 (91 FR 10749) moves all NDCs to a single 12-digit format: a 6-digit labeler code, 4-digit product code and 2-digit package code. The rule takes effect on March 7, 2033, followed by a 3-year transition. Existing 10-digit NDCs will be converted by adding leading zeros. Nothing changes on your labels yet, but make sure your systems can handle both formats.
How a foreign brand gets its own NDCs
- 1Choose a registered manufacturerThe factory must have an active FDA drug establishment registration and follow drug cGMP. A foreign establishment must name a U.S. Agent.
- 2Get your D-U-N-S numberFDA uses it to identify the company requesting the labeler code. See how to get a D-U-N-S number.
- 3Request your labeler codeAs a private label distributor, by SPL submission.
- 4Make sure the product is legal OTCMost OTC drugs are marketed under an OTC monograph. The formula, strength, claims and Drug Facts label must match it exactly. Products outside a monograph usually need an approved application.
- 5The manufacturer lists the productUsing your labeler code for each package size and type sold under your brand.
- 6Print the NDC and a correct Drug Facts labelIn the U.S. format (21 CFR 201.66).
Example: a sunscreen brand from Australia
An Australian brand has its sunscreen made by a contract manufacturer in South Korea. In the U.S., sunscreen is an OTC drug. The Korean factory needs FDA drug establishment registration and a U.S. Agent; the Australian brand requests its own labeler code as a private label distributor; the factory lists each SPF product and pack size under that code. The formula and Drug Facts label must meet the U.S. sunscreen monograph rules — an SPF claim that is fine in Australia may not be allowed in the U.S.
Common mistakes
- Using the manufacturer’s NDC on a different brand’s label without a proper listing
- Listing a product that does not meet its OTC monograph (wrong active ingredient strength or claims)
- A Drug Facts panel copied from a non-U.S. label
- An unregistered or lapsed manufacturing site — drug establishment registration must be renewed every year
- Letting the labeler code go inactive by not listing products
Drug establishment registration, NDC labeler code and U.S. Agent: $550. Drug listing $350. Drug label review $550.
Frequently asked questions
Can a company that doesn’t manufacture get an NDC labeler code?
Yes, as a private label distributor that distributes the drug in the U.S. under its own name. The registered manufacturer then lists the product using that labeler code.
Is the NDC changing?
Yes, but not yet. Under FDA’s March 2026 final rule, all NDCs move to a 12-digit 6-4-2 format from March 7, 2033, with a 3-year transition.
Does an NDC mean the drug is FDA approved?
No. An NDC identifies a listed drug. It does not mean FDA has reviewed or approved it.
What do I need to request a labeler code?
An SPL labeler code request with your company name, D-U-N-S number and contact details.
Sources
- FDA — How to request a labeler code (updated August 28, 2026)
- 21 CFR 207.33 — The National Drug Code
- Federal Register — Revising the NDC format and barcode requirements, 91 FR 10749 (March 5, 2026)
Requirements and dates checked on November 11, 2026. This article is general information, not legal advice.