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Introduction to the U.S. 

Over-The-Counter (OTC) Drug

What Is an OTC Product?

An OTC product refers to a safe and effective medication that can be used by the general public without a prescription. Examples include antiseptics, sunscreens, anti-dandruff shampoos, and acne treatments. If a product makes an OTC claim and contains active ingredients, it is classified as an OTC drug in the United States and must be registered with the FDA’s Center for Drug Evaluation and Research (CDER) for regulation.

OTC Registration Process

The FDA requires registration of any establishment (facility) that manufactures, repackages, or relabels drugs intended for use in the United States.


For products governed by an OTC Drug Monograph, the registration process involves the following steps

Step.1

Establishment Registration

(Factory/Facility Registration) 

Step.2

Request a National Drug Code (NDC)

Relabeler Code

Step.3

Drug listing 

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Introduction to the U.S. Over-The-Counter (OTC) Drug

What Is an OTC Product?



An OTC product refers to a safe and effective medication that can be used by the general public without a prescription. Examples include antiseptics, sunscreens, anti-dandruff shampoos, and acne treatments. If a product makes an OTC claim and contains active ingredients, it is classified as an OTC drug in the United States and must be registered with the FDA’s Center for Drug Evaluation and Research (CDER) for regulation.

If you launch an OTC product on the market, you must register it within five days of marketing.

In practice, however, all steps must be completed before selling the product in the U.S., as customs authorities check OTC product registration upon import. 


CHECK POINT


Annual Registration Renewal must be completed between October 1 and December 31 each year.

OTC Registration Process

The FDA requires registration of any establishment (facility) that manufactures, repackages, or relabels drugs intended for use in the United States.

For products governed by an OTC Drug Monograph, the registration process involves the following steps


Step.1

Establishment Registration (Factory/Facility Registration)

Step.2

Request a National Drug Code (NDC) Relabeler Code

Step.3

Drug listing


OTC Labeling Regulations


All OTC products must comply with 21 CFR 201 (labeling requirements for OTC drugs) as well as standard cosmetic labeling regulations.


OTC Drug Product Labeling Outline

If you launch an OTC product on the market, you must register it within five days of marketing. 

In practice, however, all steps must be completed before selling the product in the U.S., as customs authorities check OTC product registration upon import.



CHECK POINT

Annual Registration Renewal must be completed between October 1 and December 31 each year.


Building on our extensive experience in the U.S. market, Resource of K.Beauty promises to provide top-tier services to help you address FDA OTC

 (over-the-counter) compliance.



OTC Labeling Regulations


All OTC products must comply with 21 CFR 201 (labeling requirements for OTC drugs) as well as standard cosmetic labeling regulations.


Building on our extensive experience in the U.S. market, Resource of K.Beauty promises to provide top-tier services to help you address FDA OTC (over-the-counter) compliance.


Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr