FDF NDC Submissions to FDA (June–August 2025): What the Data Tells Us

Between 1 June and 25 August 2025, the U.S. FDA saw a heavy wave of Finished Dosage Form (FDF) submissions linked to National Drug Codes (NDCs).
At first glance, this may look like routine regulatory activity. But the data tells a clearer story.

This period shows where pharma companies are focusing, which product categories are moving fastest, and how competitive dynamics are shaping FDA filings, especially in OTC and consumer healthcare.

Let’s break it down.

Overall Snapshot: A High-Volume Filing Window

During this three-month window, filing activity was broad and intense.

Key numbers at a glance:

This is not a narrow market signal. It reflects wide participation across brands, products, and geographies, pointing to strong commercial momentum and regulatory readiness.

To know more about all the brands, products and companies that have submitted FDF-NDC in Q3 2025. Take a look at our detailed analysis dashboard.

Brand-Level Concentration in FDF-NDC Submissions

When we look at applicants by brand, a clear pattern appears.

Top 5 Applicants by Brand (Application Volume)

Most of these filings come from OTC, dermatology, and wellness-focused brands.

What this signals?

• High submission counts are often driven by formulation variants, pack size changes, and label updates, not entirely new products.
• OTC and consumer-facing brands move faster and file more frequently than complex prescription products.

Where Are Submissions Coming From?

Top 5 Applicant Countries

The U.S. dominates the dataset.

Key takeaway:

• Nearly 70% of all NDC submissions come from U.S.-based applicants.
• China and India play an important but secondary role, reflecting their growing participation in FDA-regulated finished products.
• Most NDC activity is still domestically driven, not outsourced.

Product Type Breakdown: OTC Leads by a Wide Margin

Applications by Product Type

• OTC drugs: 1,492 applications
• Prescription drugs: 835 applications
• Vaccines: 15 applications
• Plasma derivatives: 2 applications

OTC products alone account for ~63.6% of all submissions.

Why this matters:

• OTC products have shorter development cycles.
• They allow faster reformulation and relaunch.
• Regulatory pathways are more predictable compared to biologics or injectables.

Highly specialized categories like vaccines and plasma derivatives contribute less than 1%, showing limited filing activity in this window.

Which Products Are Driving Volume?

Here are the top 5 products that have the highest number of applications:

• Ethyl Alcohol: 146 applications
• Salicylic Acid: 83 applications
• Zinc Oxide: 75 applications
• Menthol: 45 applications
• Lidocaine: 44 applications

These ingredients are occurring at multiple areas such as topical OTC products, antiseptics, disinfectants, dermatology and pain relief formulations.

High volumes here usually mean multiple brands, strengths, formats, and packaging variations, not a surge in innovation.

Key Observations from the Data

• OTC products dominate filings, making up nearly two-thirds of total NDC submissions. Prescription drugs remain steady but selective.
• U.S. companies lead decisively, contributing ~69.4% of filings, with China (~16.6%) and India (~5.7%) following.
• High-volume OTC ingredients reinforce ongoing demand in consumer healthcare, skincare, and self-medication categories.
• Filing activity is driven more by commercial agility than by new molecular development.

What This Means for Pharma Companies?

This dashboard makes one thing clear: Short-cycle, high-volume OTC products are driving FDA NDC activity. For manufacturers and marketers, this points to:

• Faster commercialization opportunities in OTC and wellness segments
• Lower regulatory friction compared to complex prescription products
• High competition, where speed and variant strategy matter more than novelty

Prescription drugs still matter—but the action, volume, and velocity are clearly in OTC and consumer healthcare.

Find detailed analysis report on FDF NDC Submissions and more at Chemxpert

Chemxpert helps teams move beyond surface-level counts. With Chemxpert, users can:

• Track NDC and FDF submission trends across time
• See which companies, products, and ingredients are filing repeatedly
• Understand competitive density before entering crowded OTC categories
• Connect regulatory filings with supplier, API, and market intelligence

In a high-volume filing environment like this, context matters more than counts. Better data means better decisions—and fewer blind spots.

FDA NDC activity in mid-2025 was driven by speed, scale, and OTC dominance. Teams that understand these patterns early are better positioned to compete, file smarter, and move faster.

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