How to Get an NDC Number for an OTC Product You Sell Online

FDA COMPLIANCE · OTC DRUGS

Updated November 2026. Sunscreen, hand sanitizer, acne treatments, antiperspirants, anti-dandruff shampoo and fluoride toothpaste are all over-the-counter (OTC) drugs in the United States, even when they look and sell like beauty products. Marketplaces and retail buyers often ask for the NDC before they will accept these listings. This guide explains what an NDC is, the three filings behind it, timelines, and the 12-digit format change FDA finalized in 2026. It is general information, not legal advice.

What is an NDC number?

The National Drug Code (NDC) is FDA’s standard for uniquely identifying drugs marketed in the United States. Today an FDA-assigned NDC is 10 digits in three segments:

• the labeler code, assigned by FDA, which identifies the company that markets the drug under its name and label;
• the product code, which identifies the specific strength, dosage form and formulation; and
• the package code, which identifies the package size and type.

The labeler code is currently 4 or 5 digits, which is why NDCs come in several layouts. The NDC is created as part of drug listing. You do not buy an NDC on its own, and an NDC is not issued for a product that is not a drug.

Is my product an OTC drug or a cosmetic?

This question comes first, because it decides which FDA program applies. A product’s intended use, shown by its claims, decides the category. A moisturizer is a cosmetic. A moisturizer with SPF that claims to protect against sunburn is a drug. A face wash is a cosmetic. A face wash that claims to treat acne is a drug. Products that are both are regulated as drugs and must meet drug registration and listing rules, not MoCRA cosmetic listing.

Most OTC products sold online are marketed under an OTC monograph, which sets the conditions, such as active ingredients, doses and labeling, under which a category of OTC drug can be marketed without an individual application. If your product does not fit a monograph, a different pathway applies, and you should get regulatory advice before launch.

How do you get an NDC number? The three filings

FDA’s drug registration and listing instructions describe three types of submissions, each with periodic updates:

1. Establishment registration. Establishments that manufacture, repack, relabel or salvage drugs for U.S. distribution register with FDA. Foreign establishments also name a U.S. Agent. Registration is renewed every year between October 1 and December 31.
2. Labeler code request. The company that markets the drug requests a labeler code by submitting a labeler code request SPL, with the company name, DUNS number and contact details. FDA emails the assigned code. The company then submits an updated SPL confirming the code. No drugs can be listed under the code until that confirmation step is done.
3. Drug listing. Each drug is listed in SPL format with its NDC, ingredients, establishments and labeling. Listing should happen when the drug enters commercial distribution.

All registration and listing submissions are in SPL, an XML format. FDA offers its own FDA Direct portal to create and submit SPL, and SPL files created other ways go through FDA’s Electronic Submissions Gateway.

Who needs a labeler code, the brand or the manufacturer?

FDA says the labeler code identifies the company marketing the drug, and that labelers can be registered manufacturing facilities or private label distributors. One labeler code covers a company, not each facility. FDA also says a company that does not manufacture or distribute drugs in the U.S. should not apply for one, and a labeler code with no drug listings for two years may be deactivated.

For a private label brand, the choice is whether to list under your own labeler code or under your contract manufacturer’s. Listing under your own code keeps the NDC with your brand if you change manufacturers. Listing under the manufacturer’s code can be faster for a first launch. Decide this before you print labels, because the NDC on the package should match the listing.

How long does it take to get an NDC?

FDA’s FDA Direct guide says a submitted SPL goes through automated technical validation, which takes about 15 minutes, before it is accepted or rejected. The labeler code itself is assigned after FDA reviews the request, and you then confirm it. In practice, the timeline depends on having the DUNS number, establishment registration and final label ready. Missing information is the usual cause of delays.

Do OTC drug labels have to show the NDC?

FDA regulations at 21 CFR 201.2 say the NDC is requested but not required to appear on drug labels. Marketplaces and retailers often want it, and it should match the listing exactly if you show it. Separately, the Drug Facts panel, the required format for OTC labels, is mandatory.

What is changing with the 12-digit NDC?

In March 2026 FDA finalized a rule that adopts a uniform 12-digit NDC format. The rule takes effect on March 7, 2033. Until then FDA keeps assigning 10-digit NDCs. On the effective date, FDA will convert existing NDCs by adding leading zeros to segments as needed, and it will update listing files automatically. There is then a three-year transition, through March 6, 2036, for labels to switch. Nothing changes for your listing today, but if you are designing packaging that will stay in use for years, keep the change in mind.

Keeping an NDC listing current

• FDA regulations call for registrants to review and update drug listings each June and December, or certify that nothing has changed. A blanket “no changes” certification can be submitted during the October to December registration renewal period.
• Update labeler code information within 30 days of a change in contact details, business activities or the types of drugs.
• Renew establishment registration every year between October 1 and December 31.
• Check whether OMUFA facility fees apply to your OTC monograph facility. These are FDA government fees, separate from any service fees.

How Eva Commerce helps with OTC drug filings

Eva Commerce supports OTC establishment registration ($440 per year), NDC/SPL product listing ($290 per product, SPL included), labeler code requests (quoted on request), OMUFA guidance and U.S. Agent service for foreign drug establishments. Prices are on our FDA compliance services page. Because claims decide whether a product is a drug or a cosmetic, we also check how your Amazon, Walmart and TikTok Shop listings describe the product, so the listing copy matches the drug label. Our answer on what FDA registration does and does not mean covers the wording to avoid.

An NDC, registration or listing does not mean FDA has reviewed or endorsed a drug. Book a call or call 858-315-2020 to plan your OTC launch.

Frequently asked questions

How do I get an NDC number for an OTC product?

Request a labeler code, make sure the manufacturing establishment is registered, then list the drug with FDA in SPL format. The NDC is assigned as part of the drug listing.

Does an NDC number mean FDA has reviewed my product?

No. An NDC is an identifier for a listed drug. Listing and registration are filings and do not indicate FDA review or endorsement.

Can a private label brand have its own labeler code?

Yes. FDA says labelers can be manufacturers or private label distributors, and one labeler code covers the whole company.

Does sunscreen need an NDC?

Sunscreens are OTC drugs in the U.S., so they are subject to drug establishment registration and drug listing, which is where the NDC comes from.

Is the NDC changing to 12 digits?

Yes, but not until March 7, 2033. FDA will convert existing NDCs automatically, with a transition period for labels through March 6, 2036.

How often do I update an OTC drug listing?

Review listings each June and December, update any changes, or certify no changes. Establishment registration renews every year from October 1 to December 31.

Sources: FDA, How to Request a Labeler Code; FDA, Drug Registration and Listing Instructions; FDA, National Drug Code Format; FDA, National Drug Code Directory; 21 CFR 201.2 and 207.57. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA registration and U.S. Agent guide, FDA registration vs approval.