Overview of NDC: 70000-0141
The National Drug Code (NDC) 70000-0141 corresponds to the drug product "LEADER™ Mucus Relief PE - Sinus Congestion," which is an over-the-counter (OTC) medication. This product contains guaifenesin 400 mg and phenylephrine HCl 10 mg, serving as an expectorant and nasal decongestant, respectively[4].
Market Context
OTC Market Dynamics
The OTC drug market is characterized by a high volume of sales and a competitive landscape. Products like LEADER™ Mucus Relief PE are widely available and often face competition from both branded and generic alternatives. The market is driven by consumer demand for quick relief from common ailments such as sinus congestion and cold symptoms.
Regulatory Environment
The FDA's National Drug Code Directory plays a crucial role in regulating and tracking these products. Drug establishments, including manufacturers and distributors, must provide the FDA with a current list of all drugs manufactured or processed for sale in the U.S., using the unique NDC identifier[1].
Price Analysis
Current Pricing
As an OTC product, the pricing of LEADER™ Mucus Relief PE is generally set by the manufacturer and can vary based on retail channels and geographic locations. The product is typically priced competitively to attract consumers.
Price Stability
OTC drugs often experience stable pricing due to their widespread use and the competitive nature of the market. However, prices can fluctuate based on factors such as raw material costs, manufacturing expenses, and market demand.
Comparison with Prescription Drugs
Unlike prescription drugs, which often see significant price increases over time, OTC drugs tend to have more stable price trajectories. For example, prescription drugs selected for Medicare Part D negotiations have seen list price increases ranging from 20% to 55% between 2018 and 2023, whereas OTC drugs are less likely to experience such dramatic price hikes[2][5].
Price Projections
Short-Term Projections
In the short term, the price of LEADER™ Mucus Relief PE is likely to remain stable, reflecting the general stability of the OTC market. Any price changes would be minimal and driven by minor adjustments in production costs or market conditions.
Long-Term Projections
Over the long term, the price of this product may see slight increases due to inflation and potential changes in raw material costs. However, these increases are expected to be modest and in line with overall consumer price index (CPI) changes.
Market Trends and Challenges
Consumer Preferences
Consumers increasingly prefer products with multiple active ingredients that address multiple symptoms, which can influence pricing strategies. Products like LEADER™ Mucus Relief PE, which combine an expectorant and a nasal decongestant, are well-positioned in this market[4].
Regulatory Changes
Any significant regulatory changes, such as new labeling requirements or changes in FDA guidelines, could impact the pricing and availability of OTC drugs. However, these changes are typically gradual and allow manufacturers time to adjust.
Competition
The OTC market is highly competitive, with numerous brands and generic options available. This competition helps keep prices in check and encourages manufacturers to maintain competitive pricing strategies.
Key Takeaways
- Stable Pricing: OTC drugs like LEADER™ Mucus Relief PE generally experience stable pricing due to market competition and consumer demand.
- Regulatory Compliance: The product must comply with FDA regulations, including the use of the NDC identifier.
- Market Dynamics: The OTC market is driven by consumer preferences for multi-symptom relief products.
- Long-Term Projections: Prices are expected to see minimal increases, largely in line with inflation and CPI changes.
FAQs
-
What is the NDC code for LEADER™ Mucus Relief PE - Sinus Congestion?
- The NDC code is 70000-0141[4].
-
What are the active ingredients in LEADER™ Mucus Relief PE?
- The active ingredients are guaifenesin 400 mg and phenylephrine HCl 10 mg[4].
-
How is the pricing of OTC drugs like LEADER™ Mucus Relief PE typically determined?
- Pricing is determined by the manufacturer and influenced by market competition, production costs, and consumer demand.
-
Are there any significant regulatory changes expected to impact OTC drugs?
- There are no immediate significant regulatory changes anticipated, but manufacturers must always be prepared for updates in FDA guidelines.
-
How does the competitive landscape affect the pricing of LEADER™ Mucus Relief PE?
- The competitive nature of the OTC market helps maintain stable and competitive pricing for products like LEADER™ Mucus Relief PE.
Cited Sources
- FDA's National Drug Code Directory - FDA
- Medicare Drug Price Negotiation Program - ASPE - HHS.gov
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
- MUCUS RELIEF PE SINUS CONGESTION - DailyMed
- Medicare Drug Price Negotiation Program - CMS
