Yes. Any product that conforms to an OTC monograph may be manufactured and sold without an individual product license. A monograph is a regulatory standard for the labeling and ingredients for products within a specific category such as antacids, analgesics, etc. It is a kind of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling. Final monographs are published in the government’s Code of Federal Regulations (CFR). Some OTC medicines do not fall within the monograph system and require a new drug application (NDA).
