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An OTC Drug is a safe and effective drug that can be used by the general public without a prescription. Antioxidants, sunscreens, dandruff shampoos, acne care products, and skin protectants with an astringent effect (products containing salicylic acid) are classified as OTC drugs in the US.


OTC registration requirements

  • In order to register as an OTC drug, the manufacturer must check whether the product contains active substances designated by the FDA.
    • If it does, the product must be registered as an “approved drug.”
    • If it does not, the product must be registered as an “unapproved drug” (also examine the possibility of registration).
  • ­ The FDA classifies OTC drugs into roughly 80 product groups, and regulates the definition, efficacies, labeling, testing, and ingredients for each product.


Registration procedure

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