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 Snapshot

Total applications submitted: 2,344

Brands represented: 1,004

Products covered: 647

Companies involved: 655

Countries represented: 28

The 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 applications

Clé de Peau Beauté – Radiant Fluid Foundation Matte M: 24 applications

NP Thyroid: 15 applications

Quality Choice: 9 applications

Habitrol Nicotine Polacrilex: 6 applications

The 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 Countries

United States: 1,626 applications

China: 388 applications

India: 134 applications

South Korea: 43 applications

Australia: 35 applications

The U.S. accounts for the majority of submissions, while China and India emerge as key international contributors to FDA NDC filings.

Add percentage

Applications by Product Type

OTC drugs: 1,492 applications

Prescription drugs: 835 applications

Vaccines: 15 applications

Plasma derivatives: 2 applications

OTC products dominate the filing landscape, underscoring strong activity in consumer healthcare, personal care, and self-medication segments.

Top 5 Products by Application Volume

Ethyl Alcohol: 146 applications

Salicylic Acid: 83 applications

Zinc Oxide: 75 applications

Menthol: 45 applications

Lidocaine: 44 applications

These products are widely used across OTC, topical, antiseptic, and cardiovascular formulations, explaining their high submission volumes

Key Observations

OTC 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.