How to Get Ungated in OTC on Amazon?

Get Ungated in OTC on Amazon
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Staying healthy is the number one priority for everyone, but not everyone can afford pricey treatments. Many turn to over-the-counter (OTC) medicines found in local stores or online platforms like Amazon. However, Amazon has made rules for selling OTC drugs stricter to keep buyers safe – Meaning sellers have to get ungated in OTC to sell these products.
To make sure OTC drugs on Amazon are safe, Amazon works with the FDA. If you want to sell OTC drugs on Amazon, you need to meet certain standards, like getting an FDA registration. This guide explains everything you need to know to start selling OTC products on Amazon, from understanding the “ungating” concept to meeting the requirements for approval.

Meaning of Getting Ungated on Amazon

“Getting ungated” on Amazon means sellers go through a process to get permission to list and sell products in certain categories that Amazon limits or restricts. Amazon does this to maintain product quality, ensure sellers are reliable, and follow legal and safety rules. Categories like groceries, health and personal care, jewelry, automotive, and certain brands are often gated to prevent counterfeit goods or ensure consumer safety.

To get ungated, sellers apply to Amazon and have to meet specific requirements. This might include showing invoices from trusted suppliers, proving the products are authentic, and sometimes meeting extra criteria like having insurance or following certain handling and storage rules. Some sellers use Amazon ungating service to free themselves of the hassle. 

The goal is to only let honest and reliable sellers sell in these categories, keeping high standards and protecting customers.

Are OTC’s Gated on Amazon?

Yes. Over-the-Counter (OTC) products are a gated category on Amazon, meaning sellers need Amazon’s approval to get ungated in OTC before listing and selling them. This helps ensure sellers meet regulatory and safety standards, especially since OTC products relate to health. If this is too much of a hassle for you, you can also check out ungated categories on Amazon

Amazon asks for documents like invoices from trusted suppliers and may request other proofs of legal compliance to safeguard consumers and uphold marketplace integrity.

Is It Profitable to Sell OTC on Amazon?

Selling Over-the-Counter (OTC) products on Amazon can bring in profits, but it also comes with its own set of considerations and hurdles. OTC products can be profitable because of the factors below: 

Get Ungated to Sell OTC on Amazon
  • High Demand: OTC products like pain relievers, cold meds, and digestive aids are daily essentials for many people, ensuring a consistent demand and steady sales.
  • Repeat Purchases: Since OTC items are consumables, customers often return to buy them again, offering opportunities for recurring revenue.
  • Price Stability: OTC products generally maintain stable pricing, aiding in consistent profit margins.

However, selling OTC products also has its own challenges which you must consider before investing in them: 

  • Regulatory Compliance: Meeting health and safety regulations is crucial and can involve additional costs and efforts for compliance.
  • Competition: OTC products face stiff competition from other sellers, including Amazon’s own brands and established pharmaceutical companies.
  • Storage and Handling Requirements: Some OTC products need specific storage or handling, adding to operational costs.

How to Get Ungated to Sell OTC on Amazon?

Ungating Amazon’s Over-the-Counter (OTC) medication category presents unique challenges compared to other subcategories within the platform’s Health and Personal Care section. Here’s a breakdown of the steps involved to get ungated in OTC:

OTC products are a gated category on Amazon

1. Purchasing Directly from Manufacturers

When it comes to OTC medications, sellers must procure their products directly from the manufacturers. Unlike other categories where sourcing from trusted suppliers or wholesalers suffices, Amazon mandates direct purchase from the brand or manufacturer. This requirement ensures sellers can provide Amazon with the necessary Amazon Standard Identification Number (ASIN) for each listed product, demonstrating product safety and effectiveness.

2. Obtaining FDA Registration

Acquiring certification from the Food and Drug Administration (FDA) is a crucial prerequisite to get ungated in OTC. This certification validates the safety and effectiveness of OTC drugs, assisting Amazon in assessing seller compliance. Sellers can obtain FDA registration by completing the registration form on the official FDA website. Providing a screenshot of the registration page to Amazon further substantiates the legitimacy of the registration process.

3. Adhering to Labeling Guidelines

Even with FDA approval, adherence to Amazon’s labeling guidelines is paramount. Failure to comply can result in rejection of approval requests. Guidelines include:

  • Avoiding claims of FDA approval unless substantiated.
  • Refraining from unauthorized use of the FDA logo.
  • Avoiding claims of curing, mitigating, treating, or preventing disease, which should be made solely by authorized medical regulatory bodies.

4. Additional OTC Selling Approval Requirements

Various additional requirements must be met to get ungated in OTC, including:

  • Possession of a Good Manufacturing Practice (GMP) certificate.
  • Provision of a Certificate of Analysis (CoA) for each batch of OTC medication or a 510(K) Premarket Notification.
  • Submission of purchase invoices from the manufacturer or approved wholesaler, indicating orders of at least ten units of OTC drugs, alongside the brand’s information.
  • Presentation of an Employer Identification Number (EIN) or Federal Tax Identification Number to demonstrate business registration.

5. Request Approval

  1. Access Seller Central: Navigate to the ‘Inventory’ section and select ‘Add a Product’. Utilize the search bar to locate the specific OTC product you intend to list.
  2. Initiate Approval Request: Identify the product with ‘Listing limitations apply’ and proceed to click the ‘Request Approval’ button to start the application process.
  3. Submit Necessary Documents: Upload invoices and any other essential documentation directly within the application form.

6. Await Review

Upon submission, await Amazon’s review of your provided documents. This review process varies in duration, ranging from several days to weeks. Additional information or documentation may be requested by Amazon during this period.

7. Resolve Any Issues

Should your initial application to get ungated in OTC be declined, Amazon typically provides reasons for the rejection. Address these concerns, whether through acquiring supplementary documentation, altering suppliers, or ensuring compliance in other areas, and resubmit your application. Persistence is key, as multiple attempts may be necessary for approval.

Step 6: Ensure Ongoing Compliance

After you get ungated in OTC, prioritize adherence to Amazon’s ongoing requirements. This involves staying informed about regulatory updates, maintaining product authenticity and safety, and adhering to storage guidelines to ensure continued compliance.

If you want to sell any other product in the health and beauty category, make sure you know how to get ungated in health and beauty on Amazon

How Long Does It Take to Get Ungated in OTC on Amazon?

The required time to get ungated in OTC on Amazon can vary widely, depending on several factors. These include the completeness and accuracy of your documentation, Amazon’s current workload for reviews, and the specific criteria for the OTC category. 

After you’ve submitted all necessary documents and completed the application to sell OTC products, Amazon usually responds within a few days to a few weeks. Sellers commonly receive a response within 24 hours to a couple of weeks. If Amazon requires more information or documentation, it can prolong the process. Each exchange of information may add extra days or weeks to the overall timeline.

To speed up the process:

  • Ensure all documentation is accurate, clear, and fully compliant with Amazon’s requirements before submission.
  • Verify that invoices are detailed, readable, and meet the 90-day requirement.
  • Be proactive in following up if you haven’t heard from Amazon within the expected timeframe.

If you want to get ungated in other categories, make sure you know how long does it take to get ungated on Amazon

Final Thoughts

Gaining approval to sell Over-the-Counter (OTC) products on Amazon presents a valuable opportunity for sellers aiming to enter this sought-after market niche. Although the process may appear intimidating initially, understanding Amazon’s criteria and assembling comprehensive documentation can streamline and accelerate your application.

Access to selling OTC products not only diversifies your product range but also taps into a market characterized by consistent consumer demand, potentially enhancing your sales and profitability.

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  1. The inventory management tools provided by Amazon FBA are incredibly helpful. They ensure that I always have the right amount of stock available to meet customer demand.

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  3. The Amazon platform provides a streamlined returns process, ensuring customer satisfaction and reducing the burden on resellers.

  4. Reselling on Amazon allows you to leverage the platform’s reputation and trust, providing buyers with a seamless shopping experience.

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