Last updated: July 30, 2025
Introduction
The drug with National Drug Code (NDC) 00013-8303 is a pharmaceutical product situated within a complex market framework influenced by patent status, therapeutic class, competitive landscape, manufacturing costs, regulatory environment, and payer dynamics. Conducting a comprehensive market analysis and projecting future pricing necessitates understanding these key factors and current market conditions.
Product Profile and Market Context
The NDC 00013-8303 identifier corresponds to Dextromethorphan Hydrobromide and Guaifenesin Syrup—a widely used over-the-counter (OTC) cough suppressant and expectorant. Its common applications include relief from cough and chest congestion, primarily marketed under multiple brand and generic names through various distribution channels.
Note: The following analysis assumes it is a generic formulation, as NDCs often distinguish between brand and generic versions. If this NDC pertains to a branded product, the market and pricing dynamics could differ significantly.
Current Market Landscape
Market Size and Demand Dynamics
The US OTC cough and cold remedy market, estimated at over $2 billion annually, has demonstrated steady growth driven by seasonal demand, aging demographics, and increased consumer health awareness. Dextromethorphan-based formulations occupy a substantial share due to their broad acceptance and safety profiles.
The demand for dextromethorphan-guaifenesin syrups is resilient, with higher sales during colder months. The prevalence of respiratory illnesses, particularly in the post-COVID era, has further sustained market demand.
Competition and Market Players
Market competition encompasses multiple generics, private label brands, and a limited number of branded products. Major manufacturers include companies like Prestige Brands, Prestige Consumer Healthcare, and various regional OTC producers.
Brand loyalty is relatively low given the OTC nature, which consolidates generic prominence and exerts downward pressure on prices.
Regulatory and Patent Status
The active ingredients, dextromethorphan and guaifenesin, are off-patent, resulting in a competitive generic landscape. The NDC's formulation or delivery method may be proprietary, influencing exclusivity periods or branding positioning, but broad patent protections are unlikely for standard formulations.
Pricing Analysis and Historical Trends
Current Price Point
As of 2023, the average retail price for a 4 oz (120 mL) bottle of dextromethorphan-guaifenesin syrup ranges from $4 to $8 retail, depending on the brand and pharmacy setting (chain vs. independent). Wholesale acquisition costs (WAC) are typically 30-50% lower, reflecting discounts and negotiated agreements.
Price Drivers
- Generic Competition: The abundance of generic options sustains low prices.
- Manufacturing Costs: Raw material costs are relatively stable, though fluctuations in active ingredient supply can influence pricing.
- Regulatory Changes: Any FDA regulations requiring reformulation or labeling may temporarily impact pricing and production costs.
- Distribution Channels: OTC positioning means direct-to-consumer sales dominate, with minimal influence from institutional purchasers, maintaining price competitiveness.
Future Price Projections (2023–2028)
Forecast Assumptions
- Continued generic competition sustains low retail and wholesale prices.
- Seasonal demand fluctuations persist, with no significant disruptive events.
- No new patent protections or exclusivities are granted.
- Raw material prices remain relatively stable, barring unforeseen supply chain disruptions.
- Regulatory landscape remains consistent with current standards.
Projected Pricing Trends
Based on historical stability and market parity, wholesale prices for the NDC product are expected to remain within a $0.25 to $0.50 per unit range over the forecast period. Retail prices are anticipated to hover around $4 to $8 per bottle, with slight increases (~2% annually) driven by inflation, packaging costs, and distribution expenses.
Considering anticipated generic market saturation and price elasticity, average retail prices may stabilize or decline modestly, especially with increased private label penetration and direct-to-consumer marketing strategies.
Potential Market Disruptors
- Regulatory changes requiring reformulation or new safety warnings could temporarily inflate costs.
- Supply chain disruptions (e.g., raw material shortages) could elevate manufacturing expenses, influencing prices upward.
- Emergence of novel formulations or delivery systems might supplant traditional syrups, impacting demand and pricing.
- Payer Dynamics: Increasing emphasis on value-based reimbursement might pressure companies toward more competitive pricing structures.
Strategic Implications for Stakeholders
Manufacturers should continue leveraging cost efficiencies and explore differentiation through formulations or delivery formats (e.g., liquids, chewables). Distributors and pharmacists benefit from competitive pricing, but should monitor regulatory updates that could impact formulations.
Investors focusing on OTC segment companies should primarily consider the stabilizing nature of generic dominance but remain vigilant for disruptive innovations or policy shifts that could influence market share and pricing.
Key Takeaways
- The NDC 00013-8303 represents a generic dextromethorphan-guaifenesin syrup with a mature, highly competitive market.
- Current pricing remains stable, with wholesale prices around $0.25–$0.50 per unit and retail prices averaging $4–$8 per bottle.
- Future projections indicate minimal volatility, with slight downward pressure expected from competitive forces.
- External factors such as regulatory changes, raw material costs, and supply chain stability will influence pricing dynamics.
- Market resilience is underpinned by consistent demand, generic competition, and broad consumer acceptance.
FAQs
1. What factors influence the price of dextromethorphan-guaifenesin syrups?
Market competition, raw material costs, regulatory requirements, distribution channels, and seasonal demand primarily drive pricing.
2. How does generic competition impact the price of the product?
Intense generic competition maintains low prices, restricts profitable pricing margins, and encourages price parity across brands.
3. Are there pricing differences between branded and generic versions?
Yes, branded versions tend to command higher prices due to marketing premiums, whereas generics remain more competitively priced.
4. What regulatory factors could alter future pricing?
Any FDA mandates for reformulation, new safety warnings, or label updates can increase manufacturing costs and influence retail pricing.
5. How might supply chain disruptions affect this drug’s price?
Raw material shortages or logistical delays could elevate manufacturing costs temporarily, leading to price increases unless mitigated by inventory management.
References
- IQVIA. (2023). OTC Pharmaceutical Market Reports.
- U.S. Food & Drug Administration. (2022). Regulatory updates on OTC cough and cold products.
- First DataBank. (2023). Drug Pricing Data.
- SSR Health. (2022). Market Trends in Generic OTC Medications.
- Consumer Healthcare Products Association. (2023). Industry Insights on OTC Market Dynamics.
This analysis aims to provide a deep understanding of the market forces and pricing pathways relevant to NDC 00013-8303, enabling strategic decisions grounded in current and forecasted industry data.
