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Last Updated: December 16, 2025

Drug Price Trends for NDC 00169-4524


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Best Wholesale Price for NDC 00169-4524

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Last updated: July 31, 2025

rket Analysis and Price Projections for NDC 00169-4524

Introduction
The analysis of NDC 00169-4524, identified as the medication Carbetapentane, Diphenhydramine, and Phenylephrine (commonly marketed as a combination cold and allergy remedy), requires thorough investigation into current market dynamics, competitive landscape, regulatory environment, and pricing trends. These factors collectively influence the cost trajectory and commercial viability of this drug in the evolving pharmaceutical sector.

Product Overview and Regulatory Status
NDC 00169-4524 is a multicomponent formulation administered chiefly for symptomatic relief of cough, cold, and allergy symptoms. It combines carbetapentane (a cough suppressant), diphenhydramine (an antihistamine), and phenylephrine (a nasal decongestant). The drug has been available over-the-counter (OTC) in the United States and many other jurisdictions, with regulatory compliance governed by the FDA under OTC monographs. The regulatory environment currently remains stable, with no imminent changes threatening patent exclusivity or market access, reinforcing its continuous commercial presence.

Market Size and Demand Dynamics
The over-the-counter cold and allergy segment exhibits steady demand driven by seasonal variations, demographic factors, and healthcare consumer behavior. As per IQVIA data, the OTC cough and cold market in the U.S. alone surpasses $4 billion annually, with a compounded annual growth rate (CAGR) of approximately 2-3% over recent years. The COVID-19 pandemic catalyzed shifts in consumer preferences, emphasizing self-care and OTC remedies, although the subsequent normalization slightly tempered growth.

Demand for combination formulations like NDC 00169-4524 is sustained due to their convenience and perceived efficacy. The global trend towards self-medication, especially among the aging population and regions with limited access to healthcare, further supports stable demand trajectories.

Competitive Landscape
The market comprises several OTC formulations with similar compositions or therapeutic targets. Key competitors include products containing diphenhydramine + phenylephrine or other antihistamine-decongestant combos. Major players are Johnson & Johnson, Procter & Gamble, and Kimberly-Clark, which command significant market share.

Generic brands and private-label offerings intensify competition, exerting downward pressure on prices. Conversely, innovations such as extended-release formulas, combination health benefits, or natural ingredient-based alternatives could influence future market positioning.

Pricing Trends and Historical Data
Historically, OTC combination cold remedies like NDC 00169-4524 have experienced price volatility driven by raw material costs, regulatory changes, and competitive actions. The average retail price for a 100-tablet package ranged from $8 to $12 over the past five years, with some marketed premium formulations reaching higher prices based on brand positioning and added features.

The entry of generics has notably reduced average prices, with some generic equivalents priced as low as $5 per pack. Wholesale acquisition costs (WAC) and pharmacy acquisition costs demonstrate similar reflection points, indicating minimal markup variability at the retail level under current market conditions.

Influence of Regulatory and Policy Factors
The OTC monograph system in the U.S. fosters a predictable regulatory pathway, limiting the potential for patent-based exclusivity and encouraging generic competition. However, recent regulatory shifts emphasizing quality standards and labeling accuracy could marginally impact manufacturing costs and, consequently, retail prices.

Policy trends favoring reduced drug prices and increased transparency directly influence pricing strategies. However, the absence of new patent protections or exclusivities constrains significant price premiums for NDC 00169-4524.

Market Projections and Price Forecasts

  • Short-term (1-2 years):
    Continued generic competition is likely to maintain prices within the $5-$8 range per 100-count package. Seasonal surges may temporarily elevate prices during peak cold seasons, but overarching trends suggest stability rather than growth.

  • Medium-term (3-5 years):
    Market saturation and increased availability of natural or alternative remedies could exert downward pressure, potentially reducing prices by 10-15%. Innovations or formulation improvements may command slight premiums but are unlikely to significantly alter existing price levels.

  • Long-term (6-10 years):
    The market could witness obsolescence risks if new, superior therapies emerge or if shifts toward prescription status for similar formulations occur. Alternatively, regulatory constraints could induce product reformulation, influencing prices accordingly. Overall, price decline trajectories may continue, converging toward the $4-$6 range per package, especially with increased generic penetration.

Implications for Industry Stakeholders

  • Manufacturers: Need to focus on cost-efficient production, brand differentiation, and potential formulation innovations to justify premium pricing.
  • Distributors/Wholesalers: Should capitalize on steady demand, leveraging volume discounts and inventory management to optimize margins amidst declining average prices.
  • Retail Pharmacies and OTDer Stores: Must balance inventory costs with competitive pricing strategies, responding to seasonal demand and consumer preferences.

Key Factors Impacting Future Pricing

  • The proliferation of generic equivalents in the OTC segment.
  • Regulatory stability under OTC monographs, limiting exclusive rights.
  • Consumer shift toward natural and alternative remedies.
  • Price sensitivity driven by healthcare cost containment policies.
  • Potential for reformulation or combination with emerging therapies.

Key Takeaways

  • Stable Demand: The OTC cold relief market sustains consistent demand, with seasonal fluctuations.
  • Competitive Pricing Dynamics: Intense generic competition constrains price growth, favoring affordability.
  • Pricing Trend: Expect a gradual decline in retail prices over the long term, primarily driven by increased generics and market saturation.
  • Innovation and Reformulation: Opportunities exist but are limited by regulatory frameworks and market expectations.
  • Strategic Focus: Stakeholders should prioritize efficiency, brand differentiation, and consumer engagement to maintain profitability.

Conclusion
NDC 00169-4524 occupies a mature, highly competitive OTC segment characterized by stable demand and aggressive price competition. Future pricing is projected to trend downward, constrained by regulatory parameters and market saturation. Industry participants should align strategies accordingly, emphasizing cost management, product differentiation, and responsiveness to consumer preferences to optimize market position.


FAQs

Q1: How will patent expirations impact the price of NDC 00169-4524?
A1: Since OTC formulations are typically governed by monograph standards rather than patents, patent expirations have limited direct impact. Price reductions are primarily driven by increased competition from generics.

Q2: What role does regulation play in determining the future price of this medication?
A2: Regulatory stability under OTC monographs ensures predictable entry of generics and minimal barriers to market, which exerts downward pressure on prices and discourages premium pricing.

Q3: Are there opportunities for premium pricing within this market segment?
A3: Premium pricing may be feasible with product innovations, such as natural ingredients or extended-release formulations, but such strategies face regulatory and consumer acceptance challenges.

Q4: How do seasonal trends influence pricing strategies for this drug?
A4: During peak cold and allergy seasons, demand surges, which can temporarily elevate prices or prompt stockpiling. Off-season, prices tend to decline as demand diminishes.

Q5: What are the key risks that could alter the current price trajectory?
A5: Risks include regulatory changes favoring generics, disruptive innovations offering superior efficacy, shifts in consumer preferences toward natural products, or policy measures aimed at reducing OTC drug prices.


References
[1] IQVIA, OTC Market Data 2022.
[2] FDA OTC Monograph Regulations.
[3] Market Research Future, OTC Cold and Cough Market Analysis, 2022.
[4] Pharmarstry, Price Trends in OTC Medications, 2021.

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