FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
& Labeling Compliance Assistance
OTC Drug Labeling Requirements
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How is drug labeling regulated in the US?
All drugs sold in the U.S., regardless of where they are manufactured, must comply with the labeling requirements set by the FDA (FD&C Act). The drug’s classification—whether it’s OTC, prescription (Rx), homeopathic, etc.—plays a significant role in determining what information must be included on the label. According to the FDA, these labeling requirements extend beyond the physical label on the drug packaging and encompass inner packaging, marketing materials, and even content on seller websites.
Labeling issues are often the leading cause of delays in U.S. customs release or FDA import detentions. Incorrect or incomplete labeling can lead to significant delays, disrupt supply chains, and increase costs. Accurate and compliant labeling is essential to avoid these problems and ensure smooth import and distribution.
The FDA regulates the drugs to ensure they meet safety and labeling standards. A drug’s label educates consumers on its purpose, who can use it, and how to use it safely. To comply with FDA drug label regulations, the drug label must be clear and easy to understand, helping consumers compare products and conveniently follow the usage instructions. The information that must be included on a drug label typically contains the following:
● Product name and product identity
● Active ingredient name and dose unit.
● Drug purpose and the intended use.
● Warnings and necessary precautions.
● Circumstances to consult with a doctor.
● Directions for use and other instructions.
● List of inactive ingredients used in the formulation.
● Other information and the questions section.
● Manufacturer information and country of origin
● Lot numbers for production and expiration date
A drug’s ‘intended use’ is the primary factor in defining which FDA regulations will apply to a specific drug label. Drug claims that go beyond the applicable FDA category will cause the drug to leap into an unapproved category, potentially leading to FDA enforcement actions. Therefore, creating and employing compliant content is imperative when designing a new drug label.
What are OTC drug labeling requirements?
An over-the-counter (OTC) drug is a medication that can be purchased without a prescription and is considered safe and effective for public use when used according to the label instructions. The OTC Drug Facts panel is a standardized section on OTC drug labels that provides essential information in a specific order to help consumers use the OTC drug safely and effectively. It typically includes:
● Active Ingredients: the substances responsible for the drug’s effects.
● Purpose: what the drug is intended to treat or relieve.
● Uses: conditions or symptoms the drug is used for.
● Warnings: safety information, including potential side effects, interactions, and situations where the drug should not be used.
● Directions: how to use the drug, including dosage and frequency.
● Other Information: storage instructions and other relevant details.
● Inactive Ingredients: substances that do not have a therapeutic effect but are included in the formulation.
● Questions or Comments: contact information in case of need further information.
The drug fact panel requirements may vary slightly depending on the type of OTC drug label. For example, OTC homeopathic labeling in the U.S. must include a clear statement identifying it as homeopathic, and potency is typically shown as a number followed by either an X or a C. Additionally, these labels should consist of an FDA disclaimer since most homeopathic products are not FDA-approved.
How about OTC label font size and format requirements?
The FDA has detailed format requirements for drug fact panels on OTC drug labels, including alignment, punctuation, borders and lines, font size, and graphics. To ensure readability for the elderly, the FDA requires a minimum font size (6.7 points), though a smaller size (6.0 points) is allowed if space is limited. Some adjustments to the label are permitted for small packages, where more than 60% of the surface area is needed for required labeling.
It is important to note that the FDA considers the entire container’s surface for labeling, excluding areas like the tops and bottoms of cans or the necks of bottles. Products that cannot meet these requirements must be redesigned, as the FDA generally does not grant exemptions for size issues.
FDA Listing Inc. offers expert assistance with FDA OTC drug label regulations, including reviewing compliance, evaluating the need for additional directions or warnings, and creating FDA-compliant packaging and labeling.
We review your label from both regulatory and US customer perspectives, offering suggestions for appropriate wording based on standard American English. We also consider design implications and how the average American customer might interpret the label, ensuring your product resonates well in the US market. For assistance, please call or email us.
Service Details & Fees
OTC Drug Label review
Time Required
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
695 USD
4-5 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
OTC Drug Label review
695 USD
Time Required
4-5 Days
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
_______ Related Services _______