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Talk to a SpecialistTalk to a SpecialistWalgreen Company failed to properly register and list its Walgreens Sensitive Extra Whitening toothpaste (NDC 0363-1588) in violation of section 510(j) of the Federal Food, Drug, and Cosmetic Act. The company's electronic listing file submitted to FDA's Drug Registration and Listing System did not include all active ingredients present in the product's labeling—specifically, potassium nitrate was listed on the product label and Drug Facts section but was omitted from the electronic listing file, which only included sodium fluoride. This discrepancy between the labeling and the electronic filing rendered the product misbranded and prohibited its introduction into interstate commerce.