FDF NDC Submissions to FDA (June 2025 – August 2025)This dashboard provides an overview of Finished Dosage Form (FDF) submissions associated with National Drug Codes (NDCs) filed with the U.S. FDA during the period from 1 June to 25 August 2025. The analysis highlights filing volume, applicant diversity, product types, and country-wise participation.Overall SnapshotTotal applications submitted: 2,344Brands represented: 1,004Products covered: 647Companies involved: 655Countries represented: 28The data shows a high-volume filing period with broad participation across brands, products, and geographies, indicating strong regulatory and commercial activity.Top 5 Applicants by Brand (Application Volume)Tula Skincare – Radiant Skin Brightening Serum / Skin Tint SPF 30: 30 applicationsClé de Peau Beauté – Radiant Fluid Foundation Matte M: 24 applicationsNP Thyroid: 15 applicationsQuality Choice: 9 applicationsHabitrol Nicotine Polacrilex: 6 applicationsThe leading brands are largely around OTC, dermatology, and wellness categories, which shows high submission frequency driven by formulation variants and packaging configurations.Top 5 Applicant CountriesUnited States: 1,626 applicationsChina: 388 applicationsIndia: 134 applicationsSouth Korea: 43 applicationsAustralia: 35 applicationsThe U.S. accounts for the majority of submissions, while China and India emerge as key international contributors to FDA NDC filings.Add percentageApplications by Product TypeOTC drugs: 1,492 applicationsPrescription drugs: 835 applicationsVaccines: 15 applicationsPlasma derivatives: 2 applicationsOTC products dominate the filing landscape, underscoring strong activity in consumer healthcare, personal care, and self-medication segments.Top 5 Products by Application VolumeEthyl Alcohol: 146 applicationsSalicylic Acid: 83 applicationsZinc Oxide: 75 applicationsMenthol: 45 applicationsLidocaine: 44 applicationsThese products are widely used across OTC, topical, antiseptic, and cardiovascular formulations, explaining their high submission volumesKey ObservationsOTC products dominate NDC filings, accounting for ~63.6% of all submissions (1,492 of 2,344), while prescription drugs represent ~35.6% (835 applications). Vaccines and plasma derivatives together contribute less than 1%, indicating limited activity in highly specialized biologic segments during this period.U.S.-based applicants lead decisively, contributing ~69.4% of total NDC submissions (1,626 applications). This is followed by China (~16.6%) and India (~5.7%), highlighting the strong domestic focus of FDA NDC filings, with international participation playing a secondary but growing role.High application volumes for commonly used OTC ingredients such as ethyl alcohol, salicylic acid, zinc oxide, and menthol reinforce the ongoing demand for consumer healthcare, dermatology, and antiseptic products, often driven by formulation variants and packaging changes rather than new actives.What This Means?The data clearly indicates that short-cycle, high-volume OTC products are driving FDA NDC activity, with U.S. companies leading submissions. For manufacturers and marketers, this points to faster commercialization opportunities in OTC and wellness categories, while prescription products continue to see steady—but more selective—filing activity.