FDA COMPLIANCE · OTC DRUGS
Quick answer
An OTC monograph sets the conditions, such as active ingredients, uses, doses, routes of administration, labeling and testing, under which an over-the-counter drug in a given category is generally recognized as safe and effective (GRASE). If a product meets the applicable monograph and the other requirements of section 505G of the FD&C Act, it may be marketed without an approved new drug application. The Drug Facts label, required by 21 CFR 201.66, is the standard format for OTC drug labeling. It is not the same as a Supplement Facts panel, and following a monograph is not the same as FDA approving your specific product. Brands that sell OTC drugs also list the product with FDA so it receives a National Drug Code (NDC).
What an OTC monograph is not
- It is not a product-by-product approval letter. A monograph describes conditions for a category. Your product has to fit those conditions.
- It is not a Dietary Supplement Facts panel. FDA says Drug Facts labeling requirements do not apply to dietary supplements, which are labeled with Supplement Facts. See our guide to Supplement Facts vs Nutrition Facts.
- It is not an NDC. The NDC is the identifier assigned when the drug is listed with FDA. See our guide on how to get an NDC number for an OTC product.
Updated November 2026. Sunscreen, hand sanitizer, acne treatments, antiperspirants, anti-dandruff shampoo, fluoride toothpaste and many first-aid products are OTC drugs in the United States, even when they sit next to cosmetics or supplements in an Amazon or Shopify catalog. Marketplaces often ask for an NDC and a Drug Facts panel before they will accept the listing. This guide explains the monograph system after the CARES Act, what the Drug Facts label must include, and how FDA’s OTC monograph user fees fit in. It is general information, not legal advice.
Table of Contents
What is an OTC monograph?
An OTC monograph establishes the conditions under which an OTC drug in a therapeutic category, for example sunscreen or antacid, is generally recognized as safe and effective. Those conditions typically include the allowed active ingredients, uses (indications), doses, routes of administration, labeling and testing.
OTC monograph drugs may be marketed without an approved drug application under section 505 of the FD&C Act if they meet the requirements of section 505G, including the applicable conditions in an OTC monograph. If a product falls outside those conditions, it generally needs an approved new drug application, or it should not be marketed as that OTC drug.
You can read current monographs and administrative orders in FDA’s OTC Monographs@FDA resource, which is linked from FDA’s monograph reform page.
How did the CARES Act change the OTC monograph process?
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. It added section 505G to the FD&C Act, which reforms and modernizes the OTC drug review. Under section 505G(b), FDA can issue a proposed and final administrative order that adds, removes or changes GRASE conditions for an OTC monograph. Either FDA or a requestor can start that administrative order process. Requestors submit OTC Monograph Order Requests (OMORs) through FDA’s CDER NextGen portal.
This replaced the older notice-and-comment rulemaking path for many monograph changes and is the process FDA now uses to update labeling, ingredients and other GRASE conditions.
What must appear on the Drug Facts label?
FDA requires a standard Drug Facts label on OTC medicines so the same types of information appear in the same order, in a consistent style. FDA’s consumer page on the OTC Drug Facts label, and the regulation at 21 CFR 201.66, describe the content. The required headings, in order, are:
- Drug Facts (the title of the panel)
- Active ingredient(s), including the amount in each dosage unit
- Purpose(s), the product’s action or pharmacologic category
- Use(s), the symptoms or conditions the product is intended to treat or prevent
- Warning(s), including when not to use the product, conditions that need a doctor’s advice, possible interactions or side effects, pregnancy or breastfeeding warnings, and keeping the product out of children’s reach
- Directions, how much to take, how to take it, how often and how long
- Other information, such as storage and certain ingredient amounts (for example sodium)
- Inactive ingredients, such as binders, colors or flavorings
- Questions? or Questions or comments? (optional)
The outer package also carries other required information, including the statement of identity, net quantity of contents, an expiration date when applicable, a lot or batch code, and the name and address of the manufacturer, packer or distributor. FDA also expects tamper-evident packaging, with a statement describing that feature, for most OTC drugs.
Marketplace listings should match the Drug Facts panel. If you change an active ingredient, a warning or a direction, the label and the listing need to change together. A cosmetic-style front panel does not replace Drug Facts when the product is an OTC drug.
How do NDC listing and the Drug Facts label work together?
To sell many OTC drugs, the company that markets the product requests a labeler code from FDA, the manufacturing establishment registers, and the drug is listed with FDA in Structured Product Labeling format, which assigns the National Drug Code. The NDC identifies the labeler, the product and the package. It is an identifier for a listed drug, not a sign that FDA has reviewed or endorsed that specific product.
Eva Commerce files OTC drug (NDC) listings for $290 per product. The steps, the 10-digit format and FDA’s later 12-digit change are in our NDC number guide. Label review is separate: $340 for a basic formatting review and $590 for a full compliance review, as listed on our FDA compliance services page.
What are OMUFA fees?
The CARES Act also created the Over-the-Counter Monograph Drug User Fee program (OMUFA). Industry-paid fees support FDA’s OTC monograph work. These are FDA government fees, not Eva’s service fees, and they are separate from the $290 NDC listing.
FDA publishes the rates on its OMUFA program page. There are two kinds of fees:
- Facility fees, assessed on qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization (CMO) facilities. A CMO facility pays two-thirds of the fee that applies to a monograph drug facility that is not a CMO. The fee is per facility, not per product. Facilities that only make the active ingredient, or that had ceased all OTC monograph drug activities before the cutoff date in the statute and updated their registration, are not assessed this fee.
- OMOR fees, due when a person submits an OTC Monograph Order Request. FDA does not assess an OMOR fee if the request only seeks to change the Drug Facts labeling to add or strengthen a contraindication, warning or precaution, a statement about risk associated with misuse or abuse, or a dosage-and-administration instruction intended to increase safe use.
FDA’s published rates are:
- Fiscal year 2026: monograph drug facility $19,188; CMO facility $12,792; Tier 1 OMOR $587,529; Tier 2 OMOR $117,505.
- Fiscal year 2027: monograph drug facility $47,891; CMO facility $31,927; Tier 1 OMOR $614,608; Tier 2 OMOR $122,921.
For fiscal year 2027, FDA says facility fees are due in two equal installments, the first on October 1, 2026 and the second on February 1, 2027 (or the first business day after an appropriations act is in effect, if that is later). For fiscal years 2028 through 2030, the facility fee is due on October 1 of the fiscal year, or the first business day after the appropriations act, whichever is later. OMOR fees are due on the date of submission. FDA states that large and small companies pay the same applicable facility or OMOR fee. Paying PDUFA, GDUFA or other user fees does not remove an OMUFA obligation.
The FY 2027 facility fee is higher than the FY 2026 fee. FDA explains that increase on its OMUFA page, including a one-time downward adjustment that applied in FY 2026 when the payment date moved. Confirm current amounts and due dates on FDA’s page before you pay, because FDA updates the Federal Register notices each year.
How Eva Commerce helps
Eva Commerce does not prepare OMORs, pay OMUFA facility fees or act as your regulatory lawyer. We file the OTC drug (NDC) listing ($290 per product), provide U.S. Agent service for foreign establishments ($250 a year), and review labels ($340 basic, $590 full). If the same brand also sells supplements or cosmetics, we can keep those filings and panels in the right category so a Drug Facts product is not labeled as a supplement, or the reverse.
Because Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth, the listing can repeat the Drug Facts information rather than a rewritten claim. Book a call or call 858-315-2020 to see which OTC filings apply to your products.
Frequently asked questions
What is an OTC monograph?
It is FDA’s set of conditions, including active ingredients, uses, doses, routes, labeling and testing, under which an OTC drug in a category is generally recognized as safe and effective. A product that meets the applicable monograph and section 505G may be marketed without a new drug application.
What is a Drug Facts label?
It is the standard OTC drug label required by 21 CFR 201.66. It lists active ingredients, purpose, uses, warnings, directions, other information and inactive ingredients in a fixed order so consumers can compare products and use them correctly.
Does a monograph mean my OTC product is FDA approved?
No. A monograph describes conditions for a category. Marketing under a monograph is not the same as FDA approving your individual product. An NDC identifies a listed drug; it is not an approval either.
What is the OMUFA Tier 1 fee?
It is FDA’s fee for a Tier 1 OTC Monograph Order Request. FDA published $587,529 for fiscal year 2026 and $614,608 for fiscal year 2027. The fee is due when the request is submitted, unless the request is a safety-related Drug Facts change that the statute exempts. This is an FDA government fee, not Eva’s $290 NDC listing fee.
Who pays the OMUFA facility fee?
Qualifying owners of OTC monograph drug facilities, including certain contract manufacturing organizations. The fee is assessed per facility. Confirm whether your site meets the statutory definition on FDA’s OMUFA page, because some activities, such as only making the active ingredient, are not assessed this fee.
Can Eva Commerce file my NDC and review the Drug Facts label?
Yes. Eva files OTC drug (NDC) listings for $290 per product and reviews labels for $340 (basic) or $590 (full). We do not pay OMUFA fees or submit monographs for you. Book a call or call 858-315-2020.
Sources: FDA, OTC Drug Review and OTC Monograph Reform in the CARES Act; FDA, The Over-the-Counter Drug Facts Label; eCFR, 21 CFR 201.66; FDA, Over-the-Counter Monograph Drug User Fee Program (OMUFA); FDA, OTC Drug Review Process and OTC Drug Monographs. General information, not legal advice.
