MoCRA Product Listing Requirements (FDA Form 5067), Explained

Alok Naik, MS- Regulatory Affairs
Jul 5
3 min read

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

Facility registration gets the headlines, but product listing is where many brands stumble — because it's a separate, ongoing obligation tied to every individual product. Under MoCRA, the Responsible Person must list each marketed cosmetic with FDA and keep that listing current. Here's what's required.

What is cosmetic product listing under MoCRA?

Under Section 607(c) of the FD&C Act, the Responsible Person must submit a cosmetic product listing to FDA for each cosmetic product marketed in the U.S. Listing is submitted on Form FDA 5067, through FDA's Cosmetics Direct electronic system.

Listing is not the same as facility registration. Registration covers the facility (Form 5066); listing covers each product (Form 5067). A single facility can have many product listings. (For the registration side, see how to register a foreign cosmetic facility.)

What information does a product listing require?

A cosmetic product listing generally captures:

The facility registration number of each facility where the product is manufactured or processed.

The name of the Responsible Person and the name of the cosmetic product, as they appear on the label.

The applicable cosmetic category or categories.

A list of ingredients, including fragrances, flavors, and colors.

Relevant product identifiers as required by FDA.

Because the listing pulls directly from your label and formulation, accuracy across all three — label, listing, and registration — is essential. Mismatches are a common trigger for FDA follow-up.

Who has to list, and how often?

The Responsible Person (the manufacturer, packer, or distributor named on the label) holds the listing obligation — see Responsible Person vs. U.S. Agent.

Listings should be updated annually, and whenever there's a material change to the product (reformulation, new label, discontinuation).

Are any products or businesses exempt?

Certain small businesses may be exempt from product listing based on the statutory average-annual-sales threshold. As with registration, that exemption does not apply to higher-risk products — those that contact the eye's mucous membrane, are injected, are intended for internal use, or alter appearance for more than 24 hours under customary use. If you make those, you must list regardless of size.

A practical listing checklist

Confirm the product is a cosmetic (not an OTC drug, which lists differently via NDC/SPL).
Map each product to its manufacturing facility's registration number.
Pull the ingredient list straight from the validated label to keep data consistent.
Submit on Form 5067 via Cosmetics Direct.
Calendar annual updates and tie listing maintenance to any label or formula change.

Have a portfolio of SKUs to list? Axentra manages cosmetic product listings end-to-end, keeps them aligned with your registration and labels, and maintains annual updates so nothing drifts out of compliance. Get listing support.

See the complete obligation set on our MoCRA cosmetics compliance page and the official requirements on FDA's MoCRA page.

Frequently asked questions

What is required for MoCRA cosmetic product listing?

The Responsible Person must list each marketed cosmetic product with FDA on Form 5067, including the manufacturing facility's registration number, the Responsible Person and product name, the product category, and a full ingredient list. Listings are updated annually.

Is product listing the same as facility registration?

No. Facility registration on Form 5066 covers the facility; product listing on Form 5067 covers each individual product. One facility can have many product listings.

How often must cosmetic product listings be updated?

Annually, and whenever there is a material change to the product such as a reformulation, new label, or discontinuation.

Which form is used for cosmetic product listing?

FDA Form 5067, submitted through FDA's Cosmetics Direct electronic system.