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OTC FDA
Not sure if your product needs OTC FDA compliance or MoCRA registration? We help you determine the right path for US market access.
Over-the Counter Products in the United States
OTC FDA Monograph Compliance and Registration Services
Launching an OTC product in the US requires strict compliance with FDA regulations. At Cosmeservice, our OTC regulatory services guide you through the OTC monograph framework and the drug registration process. As a result, your formulas, labeling and documentation meet legal requirements for a safe and successful market entry.
Comply nowWhat are OTC products?
In the United States, OTC drugs are non-prescription products that treat, prevent or relieve health conditions, such as acne, sunburn or dandruff. Although they may look like cosmetics, their intended use places them under FDA drug regulations. Therefore, knowing whether your product is a cosmetic or OTC is the first step toward OTC FDA compliance.
Common OTC product categories include:
- Sunscreens
- Anti-acne products
- Antiperspirants with therapeutic claims
- Dandruff shampoos
- Oral care products with fluoride
OTC FDA requirements for product compliance
OTC monograph compliance is essential for marketing over-the-counter drugs in the US. For this reason, our experts guide cosmetic and personal care brands through FDA requirements, labeling rules and regulatory updates. In this way, you can launch your products safely and legally.
Companies that manufacture or distribute OTC drugs in the US must register with the FDA. In addition, they must complete drug listing through 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
Since the implementation of MoCRA (Modernization of Cosmetics Regulation Act), many companies are unsure whether their product must comply with MoCRA, OTC rules 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.
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FAQs
How do I know if my product falls under OTC FDA regulations?
If your product makes claims about preventing or treating a condition (e.g., “treats acne”), it may fall under OTC drug regulations. In that case, we can help you classify it correctly.
Can a product fall under both MoCRA and OTC?
Yes, in some cases. For example, a sunscreen must meet OTC FDA requirements. However, certain MoCRA requirements, such as fragrance allergen labeling, may also apply.
Do I need FDA approval to sell an OTC product?
Not always. If your product conforms to an existing FDA monograph, you don’t need pre-approval. However, you still need FDA registration and listing.
What happens if my OTC product doesn’t meet FDA requirements?
Your product may face detention at customs, recalls or other enforcement actions. That’s why proper regulatory compliance is critical.
Can I manufacture OTC products outside the USA?
Yes, but you must register your foreign facility with the FDA. In addition, your products must comply with all US requirements before importation.
What is the Drug Facts label, and is it mandatory?
Yes. The FDA requires the Drug Facts label on all OTC drug products. Moreover, the label must follow the standardized format that the FDA defines.
