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How do you know if an over the counter drug is safely processed and safe to use?

I have not heard of the brand SDA Laboratories before, so tried searching online to see if it has any safety certifications, but did not know what to search for. So also, what website should I use to check if a drug is safe and has passed 3rd party QC (quality control)? The FDA website to check for recalls?

Cetirizine made and sold by SDA Laboratories is listed as being in the NDC (National Drug Codes List) under the number ndc 66424-564-01

Amazon link to the antihistamine made by SDA Laboratories, Cetirizine HCl 10mg Tablets:

SDA made Cetirizine

This is said on the NDL website about OTC drugs:

FDA warning

Here is an example of a drug listed in the NDC (National Drug Codes List)

https://ndclist.com/ndc/50458-564/package/50458-564-01

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  • Voted to close because answers are likely to be opinion-based. That said, I'm not a fan of finding Amazon links here. As an aside, I doubt that an issued recall is a level of safety that would be useful in this case. – Thomas Sep 6 '20 at 19:11
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    @Thomas I'm okay with a screen shot of the amazon page (though it's not necessary to understand the question), but I agree regarding actual links to amazon products. I edited to remove that. I'm undecided about it being opinion based, so I'll give it some time to see if others agree with you or if someone can provide a factual answer. – Carey Gregory Sep 6 '20 at 22:01
  • I think his/her question contains some important points that will help this community evolve further. I think his/her attitude looking for review reports and package inserts is very good. So I disagree with the deletion of this thread. I'm asking a question that looks for evidence for drugs from a broader perspective. I think we should make more use of review reports and package inserts. (Of course we need a critical perspective on those as well.) – Blue Various Oct 31 '20 at 2:57
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Just for a comment;

I have a Q&A about the approval route for drugs, but according to FDA's website, drugs and OTCs have different approval routes. Therefore, the way you look for evidence about OTC may be different.

The Amazon's site of this product has following description;

Legal Disclaimer
Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.

But it is certainly strange that Cetirizine HCl is being treated as a dietary supplement. I believe there is sufficient reason for the questioner to be confused.

■Who is the Sda Laboratories ?
According to this site, sda Laboratories Inc. labeler's code (NDC) is 66424. The labeler has 12 products that have an assigned National Drug Code. Thus, the SDA appears to be a company that has at least an approved OTC.

■FDA's OTC list
The FDA's list of OTCs is this site but when I try to find an OTC that has apparently been approved, I don't get any hits. This database doesn't seem to be user-friendly in the least.

■FDA says;
This FDA's site has following descriptions;

For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Many of these monographs are found in section 300 of the Code of Federal Regulations.
Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.

If it's OTC monograph drugs, then maybe they don't need FDA approval. However, I have yet to find a list of FDA's OTC monographs.


I'm still learning how to find out what basis the drug authorities used to evaluate the effectiveness and safety of the product.

If there are any errors or constructive comments, I welcome them.


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