NDC vs CPLN vs FURLS

🇺🇸 United States · Federal FDA terminology · Reviewed 25 August 2026

Jurisdiction🇺🇸United StatesFederal scope

NDC vs CPLN vs FURLS at a glance

The fastest way to stop mixing these up is to see the same six questions answered for all three at once.

The terminology warning: FDA uses the full term; TikTok uses “CPLN”

So when a form asks for a CPLN, translate it before you act: it is asking whether the product has been listed with FDA and what number that listing carries. That is a question about a filing you either made or did not make.

NDC: a drug identifier, not a seal

The National Drug Code is FDA’s identifier for a drug. It has three segments — a labeler code, a product code and a package code — and it identifies a listed drug down to package size and type. Under 21 CFR 207.33, FDA assigns the labeler code; the manufacturer, repacker or relabeler then proposes the full NDC when it submits listing information, and FDA assigns it on receipt. A proposed NDC can be reserved up to two years before the drug is listed, and the reservation lapses if the listing never arrives.

That workflow sits inside the drug regime: establishments register, registrants list each drug made for commercial distribution, and listing information is updated twice a year, in June and December. FDA describes three separate submissions: establishment registration, labeler code request, and drug listing. An NDC is an output of the third one.

Now the part that gets misused. FDA’s NDC Directory page says plainly that inclusion in the Directory does not indicate FDA verified the information or that the products are FDA-approved, that assignment of an NDC does not denote approval, and that inclusion or assignment does not even mean the product is a drug as defined by federal law. The content of each entry is the responsibility of the labeler who submitted it. The regulation goes further: under 21 CFR 207.37, a product may be deemed misbranded if an NDC is used to denote or imply FDA approval, or if it is applied to products outside the relevant parts — FDA names dietary supplements and medical devices as examples.

If a marketplace has asked you for an NDC on an over-the-counter drug or a medicated cosmetic, the platform-specific walkthrough is which FDA and NDC documents apply to OTC drugs and medicated cosmetics.

The cosmetic product listing number: a different regime entirely

MoCRA created two separate cosmetic records, and confusing them is the most common error in this area. Manufacturers and processors register their facilities. The responsible person — the manufacturer, packer or distributor whose name appears on the label — lists each marketed product, including its ingredients. Those can be two different companies, and they run on different clocks: facility registration renews every two years from the initial registration date, while product listing is updated annually.

Each record has its own identifier. FDA uses the FDA Establishment Identifier (FEI) as the required facility registration number, and it must be obtained before the facility registration is submitted. The product listing number is the product-level one. They are not interchangeable, and handing over an FEI when someone asked about a product listing answers a different question.

Submission runs through Cosmetics Direct at direct.fda.gov, or alternatively through ESG NextGen, SPL authoring software including SPL Xforms, or the paper forms — Form FDA 5066 for the facility, Form FDA 5067 for the product. FDA documents these routes separately from FURLS.

Whether the duty attaches to you at all is a separate question: MoCRA exempts certain small businesses from both registration and listing, with four carve-outs that remove the exemption regardless of revenue, and further exemptions exist for certain products and facilities subject to drug and device requirements. For the seller-facing version of that analysis, see when a cosmetic seller actually owes MoCRA registration or a product listing.

FURLS: a system, not a number

FURLS stands for FDA’s Unified Registration and Listing System. For medical devices, FDA states that registration and listing information is submitted using FURLS and its Device Registration and Listing Module (DRLM), and that each owner or operator needs an account ID and password to use it. There are two account types — owner/operator and official correspondent — and FDA warns firms never to create a second account if they already have one, because it locks them out of their existing registration.

FURLS is reached through FDA Industry Systems at access.fda.gov. The systems index there shows how much wider the family is than devices: alongside the Device Registration & Listing Module sit the Food Facility Registration Module, acidified and low-acid canned foods, the Export Listing Module, several export-certification systems, the FSVP importer portal, laboratory accreditation modules, qualified facility attestation, shell egg producer registration, third-party program modules and biological product deviation reporting.

Two more boundaries worth holding. First, FURLS produces no certificate. FDA states that it does not “certify” devices, does not issue registration certificates to device facilities, and does not certify the registration information itself — and that a registration-and-listing database entry does not denote approval, clearance or authorization. FDA adds that firms displaying such certificates to imply FDA review or approval misbrand the device.

Second, registration and listing are not premarket review. A device requiring premarket clearance or approval can only be listed after that submission is cleared or approved. Listing follows the premarket route; it does not substitute for it. Device establishment registration itself runs annually from 1 October to 31 December for each fiscal year. The seller-facing version is who has to produce 510(k) and FURLS evidence for medical devices.

Which one applies to your product

Classification by intended use decides this, and it decides everything downstream. A moisturiser is a cosmetic; the same moisturiser sold to prevent sunburn is a drug. Work out the category first, then the record.

Do not submit the wrong proof

Most rejections in this area are not compliance failures. They are the right document for the wrong regime, or a private document presented as a government one. Run this before you upload anything.

1. Confirm the category by intended use first. Every answer below changes if the product is a drug rather than a cosmetic, or a device rather than either.
2. Do not send an NDC for a cosmetic, supplement or device. FDA names dietary supplements and medical devices as examples of products an NDC should not be applied to, and doing so can render a product misbranded.
3. Do not send an FEI when a product listing number was requested. The FEI identifies a facility. It says nothing about a specific product.
4. Do not send a facility registration when a product listing was requested — or the reverse. In cosmetics these are different obligations with different duty holders and different renewal cycles.
5. Do not send a FURLS account screenshot as proof of anything about a product. An account is access. The record inside it, with its registration and listing numbers, is the thing that carries meaning.
6. Do not send anything described as an “FDA registration certificate”. FDA does not issue them for device facilities, and does not issue certificates for cosmetic facility registration or product listing. A vendor’s certificate is a private document about a private service.
7. Do not describe any of the three as “FDA approved”. Registration and listing records are administrative filings. Approval, clearance and authorization are separate determinations reached by separate routes.
8. Check the record is current before you send it. A lapsed registration or a listing that was never updated is worse than no document, because it is checkable.

What none of the three prove

What each record does show is that specific information was submitted to a specific FDA system by a specific party. That is genuinely useful — it is checkable, dated and attributable. It is simply not the same as FDA having reviewed the product.

Keep three words apart while you are here. A device is cleared through a 510(k) order. A product is approved through a premarket application. A facility or product is registered or listed, which is neither of the other two. The sibling guide how facility registration and product listing differ works through that split across all four FDA regimes.

Where to check each record

Verification routes are domain-specific, and none of them is a general-purpose “FDA number” lookup.

• A listed drug: FDA’s National Drug Code Directory, which is built from the SPL listing files labelers submit and is updated daily. Note FDA’s own caveat that the Directory does not contain every listed drug.
• A listed cosmetic product: your listing record and the product listing number assigned to it. There is no public MoCRA lookup equivalent to the NDC Directory, so the evidence is the submission record itself.
• A registered device establishment: FDA’s Establishment Registration & Device Listing database. For premarket status, FDA points to Devices@FDA for approved and cleared products, the De Novo database, and its emergency use authorization listings.

If you are being asked for evidence by a marketplace rather than by FDA, that is a different exercise again — platform document policies are set by platforms, not by federal law, and satisfying one is not evidence about the other. Our approach to sourcing and verification is set out in how we verify this.

Doing it yourself versus paying someone

Two facts should frame the decision. FDA states that firms offering to help facilities register are not affiliated with it, that it has contracted with no firm to register facilities, and that it does not require anyone to hire someone to complete the online registration process.

That does not make paid help irrational. A foreign establishment with no United States presence has genuine agent requirements. A catalogue that mixes own-brand cosmetics, a medicated variant and a resold device involves a role analysis that is legitimately hard. Recovering an FURLS account nobody at the company can still log into is a real service. What you are buying is time and judgement — not a government document, and not a faster answer from FDA.

To see what these services actually cover against the free FDA route, compare what FDA registration services actually do. For the device-specific route, see 510(k) regulatory services compared. Both are editorial comparisons, not a substitute for working out which filing duty applies to you.

Frequently asked questions