Last updated: February 24, 2026
What is the drug associated with NDC 00051-8462?
NDC 00051-8462 identifies Dextromethorphan HBr Liquid, typically used as an antitussive in cough suppressants. This formulation is marketed primarily in over-the-counter (OTC) products. The drug's core active ingredient, dextromethorphan, is available in multiple strengths and formulations, often in combination products.
How is the current market landscape structured?
Market Size and Key Players
- Market Value: The global cough and cold remedy market was valued at approximately $7 billion in 2022 (Statista, 2023). Dextromethorphan-based products constitute around 70-80% of OTC cough remedies by volume.
- Major Manufacturers: Johnson & Johnson, Procter & Gamble, and Reckitt Benckiser dominate the OTC segment containing dextromethorphan.
- Distribution Channels: Retail pharmacy chains and online outlets account for the primary sales volume.
Regulatory Context
- Approved OTC in the US under OTC monograph for cough suppressants.
- Regulations restrict certain formulations containing dextromethorphan, especially concerning misuse potential (DEA scheduling considerations).
Market Dynamics
- Growing demand driven by health awareness and self-medication trends.
- Increasing availability online, particularly in markets with limited pharmacy access.
- Ongoing public health campaigns to discourage misuse.
Price Point Overview and Trends
Current Pricing Landscape
| Attribute |
Description |
| Average retail price (per 4 oz bottle) |
$3.50 – $7.00 |
| Wholesale acquisition cost (WAC) |
$2.00 – $4.50 |
| Price variance factors |
Brand name vs. generic, bottle size, formulation, purchasing channel |
Trends and Drivers
- Generics: Standardized discounts over branded OTC products, leading to more stable pricing.
- Online Sales: Slightly lower prices due to reduced distribution costs; price fluctuations common.
- Supply Chain Issues: Short-term price increases observed during disruptions (e.g., pandemic impacts on manufacturing and distribution).
Projected Price Trends (Next 2-5 Years)
Short-term (1–2 years)
- Prices tend to stabilize with continued generic penetration.
- Slight erosion of retail prices expected as online competition intensifies.
- Possible minor increases due to inflation and supply chain costs.
Medium-term (3–5 years)
- Price reductions expected as novel formulations or bundling strategies reduce end-user costs.
- Increased regulation or public health measures targeting misuse could influence pricing strategies.
- Market saturation may exert downward pressure, especially with entrance of new generics.
Key Factors Influencing Future Pricing
| Factor |
Impact |
Observation |
| Regulatory changes |
Variable |
Stricter controls could increase costs; relaxed regulations could lower prices in some segments. |
| Innovation |
Moderate |
New delivery methods (e.g., sustained-release) may command premium pricing. |
| Market Competition |
High |
Entry of additional generics or OTC brands reduces prices. |
| Supply Chain |
Moderate |
Disruptions can cause price spikes; stabilization expected with global logistics normalization. |
Strategic Considerations for Stakeholders
- Manufacturers should monitor regulatory shifts and patent landscapes for potential opportunities or risks.
- Investors need to account for generic-driven price declines, counterbalanced by potential new product launches.
- Distributors benefit from increased online sales, but should prepare for margin pressures.
Summary
The drug associated with NDC 00051-8462, primarily dextromethorphan HBr liquid, operates in a mature, highly competitive OTC market. Its pricing remains relatively stable but is susceptible to generics, regulation, and supply chain dynamics. Over the next five years, prices are expected to trend downward due to increased competition, with occasional volatility linked to external factors such as public health policies or supply disruptions.
Key Takeaways
- Volume dominates sales, with OTC products heavily influenced by generics.
- Prices are stable but show a declining trend over the medium term.
- Market growth remains steady due to consumer demand and self-medication trends.
- Regulatory and supply chain changes can lead to short-term price fluctuations.
- Competition from online outlets continues to pressure retail pricing.
FAQs
Q1: How do regulatory changes impact OTC dextromethorphan pricing?
Regulations restricting misuse or requiring packaging reforms can raise manufacturing costs, leading to higher retail prices. Conversely, deregulation may reduce compliance costs, lowering end-user prices.
Q2: What is the competitive landscape for dextromethorphan liquids?
It is dominated by generic formulations from multiple manufacturers, with branded products at a premium. Entry barriers are low given OTC status, encouraging new entries.
Q3: How significant is the role of online sales in current pricing?
Online platforms often offer lower prices by reducing distribution costs, increasing price competition and market penetration.
Q4: What factors could disrupt the current price stability?
Supply chain disruptions, regulatory crackdowns, and new formulations could cause volatility. Additionally, public health policies targeting misuse can impact availability and pricing.
Q5: Are there any recent innovations affecting this market?
Development of formulations with sustained-release mechanisms or combination products can command higher prices, but these are currently niche segments.
References
- Statista. (2023). Market for cough and cold remedies worldwide. [Data set].
- U.S. Food & Drug Administration. (2022). OTC Drug Monograph for Cough Suppressant. Retrieved from www.fda.gov.
- IMS Health. (2022). OTC market overview. [Report].
- Health Canada. (2022). Regulation of cough and cold products. [Official document].
- MarketWatch. (2023). OTC drug pricing trends. [Article].
