+34 603 445 673
OTC FDA
Not sure if your product needs OTC compliance or MoCRA registration? We help you determine the right path for U.S. market access.
Over-the Counter Products in the United States
OTC Monograph Compliance and FDA Registration Services
Launching an OTC product in the U.S. requires strict compliance with FDA regulations. At Cosmeservice, we guide you through the OTC monograph framework and drug registration process, ensuring your formulas, labeling, and documentation meet legal requirements for safe and successful market entry.
Comply nowWhat Are OTC Products?
In the United States, OTC are non-prescription products intended to treat, prevent, or relieve health conditions, such as acne, sunburn, or dandruff. While they may look like cosmetics, their intended use makes them subject to FDA drug regulations. Knowing whether your product is a cosmetic or OTC is the first step toward regulatory compliance.
Common OTC cosmetics categories include:
- Sunscreens
- Anti-acne products
- Antiperspirants with therapeutic claims
- Dandruff shampoos
- Oral care products with fluoride
FDA Requirements for OTC Product Compliance
OTC monograph compliance is essential for marketing over-the-counter drugs in the U.S. Our expert services guide cosmetic and personal care brands through FDA requirements, labeling rules, and regulatory updates to ensure safe and legal product launches.
Manufacturing or distributing OTC drugs in the U.S. requires registration with the FDA and drug listing via the Drug Registration and Listing System (DRLS).
OTC products must follow Good Manufacturing Practices for drugs, which are more stringent than cosmetic GMPs.
Non-compliance can lead to detentions by the FDA and refusal of entry by U.S. Customs.
MoCRA or OTC? Find the Right Compliance Path for Your Cosmetics
With the implementation of MoCRA (Modernization of Cosmetics Regulation Act), many companies are unsure whether their product must comply with MoCRA or OTC, or both.
In general:
- MoCRA applies to most cosmetic products.
- OTC drug regulations apply to products that make therapeutic claims or include active drug ingredients.
Cosmeservice helps you assess your product and determine the right regulatory path to avoid misclassification and ensure smooth market access.
Experts in OTC FDA Compliance
- Evaluation of cosmetic vs OTC classification
- Support with FDA Establishment Registration & Product Listing
- Review of OTC-compliant labeling (Drug Facts format)
- Guidance on GMP compliance for OTC drugs
- Full regulatory support for market access in the U.S.
Looking to Register OTC Products in the US?
We guide you through FDA OTC compliance, including drug listing, establishment registration, and labeling requirements.
Rely on Cosmeservice for expert regulatory support services, clear, fast, and aligned with your business needs.
What our clients say about us
FAQs
If your product makes claims related to prevention or treatment of a condition (e.g., “treats acne”), it may fall under OTC drug regulations. We can help you classify it correctly.
Yes. For example, a cosmetic sunscreen must comply with OTC compliance and may also be subject to certain MoCRA requirements like facility registration or adverse event reporting.
Not always. If your product conforms to an existing FDA monograph, pre-approval is not required—but FDA registration and listing still are.
Your product can be detained at customs, recalled, or face enforcement actions. Proper regulatory compliance is critical.
Yes, but your foreign facility must be registered with the FDA, and products must comply with all U.S. requirements before importation.
Yes. The Drug Facts label is required on all OTC drug products and must follow a standardized format defined by the FDA.
