Last updated: February 20, 2026
What is the Drug?
The National Drug Code (NDC) 16714-0167 corresponds to Dextromethorphan HBr oral solution, a cough suppressant indicated for temporary relief of cough caused by minor throat and bronchial irritation.
Market Overview
Dextromethorphan HBr is a component of over-the-counter (OTC) and prescription cough and cold formulations. The market has shown consistent growth driven by increased demand for symptomatic relief products, especially during respiratory illness seasons.
Key Market Segments
- OTC cough syrups and lozenges: Comprise approximately 85% of the market.
- Prescription formulations: Represent about 15%, mainly for severe cough management.
Competitive Landscape
Major players include Johnson & Johnson, Procter & Gamble, and Perrigo, focusing on both branded and generic products.
Regulatory Status
- OTC availability allowed under FDA monograph.
- No recent major recalls linked to NDC 16714-0167.
- Market entry barriers are low, with numerous generics available.
Market Size and Growth Trends
Based on IQVIA data:
| Year |
Total US Market (USD millions) |
CAGR (2018-2022) |
| ------- |
------------------------------ |
------------------ |
| 2018 |
1,200 |
3.5% |
| 2019 |
1,240 |
3.4% |
| 2020 |
1,310 |
5.6% (peak due to COVID-19) |
| 2021 |
1,350 |
3.1% |
| 2022 |
1,400 |
3.7% |
Growth has been steady, with peaks corresponding to seasonal respiratory outbreaks.
Price Projections
Current Wholesale and Retail Pricing
| Specification |
Price (USD) |
Notes |
| 4 oz (120 mL) OTC bottle |
$5.00–$7.00 |
Retail, varies regionally |
| Prescription 60 mL vial |
$10.00–$15.00 |
Wholesale price for generic |
Future Price Trends (2023–2027)
Considering factors like increased generic competition and manufacturing costs:
- Wholesale prices are expected to decline marginally (~2-3%) annually.
- Retail prices may remain stable or slightly increase (~1-2%) due to inflation and distribution costs.
- Premium formulations (e.g., additive-free, organic) could sustain higher price points, up to $10 for OTC 4 oz bottles over the forecast period.
Influencing Factors
- Generic Entry: Suppresses prices, promotes affordability.
- Regulatory Changes: Stricter quality standards or new labeling requirements could marginally increase costs.
- Supply Chain Dynamics: Raw material availability (e.g., dextromethorphan API) influences pricing; recent shortages could sustain higher prices temporarily.
- Market Demand: Seasonal fluctuations influence pricing and inventory strategies.
Pricing Compared to Similar Products
| Compound |
Average OTC Price (USD) |
OTC/Prescription Ratio |
| Dextromethorphan (NDC 16714-0167) |
$5.00–$7.00 (4 oz) |
85% OTC |
| Guaifenesin |
$4.00–$8.00 (4 oz) |
80% OTC |
| Diphenhydramine |
$4.50–$6.50 (4 oz) |
70% OTC |
Dextromethorphan products are competitively priced yet see variation based on formulation and branding.
Key Market Dynamics
- Seasonality: Demand peaks in winter months.
- Regulatory Environment: Changes affecting OTC labeling could impact packaging costs.
- Consumer Preferences: Shift toward natural and additive-free formulations may create niche markets.
- Generic Competition: Consistent with price suppression, particularly with low entry barriers.
Risk Factors
- Patent challenges or litigation could delay new product launches.
- Supply chain disruptions may destabilize pricing.
- Changes in FDA regulation or monograph updates could impact formulations and pricing.
Key Takeaways
- The market for NDC 16714-0167 remains stable with modest growth.
- Prices are trending downward at the wholesale level, with retail prices remaining relatively stable.
- Competition and supply chain factors heavily influence pricing dynamics.
- Opportunities exist for premium formulations to command higher prices.
- External factors such as seasonal demand and regulatory changes affect overall market stability.
FAQs
Q1: What is the primary market for NDC 16714-0167?
A1: The primary market comprises OTC cough suppressants sold as syrups or lozenges, accounting for roughly 85% of the product's sales.
Q2: How does generic competition impact pricing?
A2: It drives prices down, with wholesale prices decreasing by approximately 2-3% annually due to increased availability of generics.
Q3: Are there regulatory risks that could affect pricing?
A3: Yes. Changes in FDA monograph or labeling requirements could increase manufacturing costs or restrict formulations, influencing prices.
Q4: What are the main factors influencing future prices?
A4: Supply chain stability, raw material costs, competition levels, and seasonal demand.
Q5: Is there growth potential for premium formulations?
A5: Yes. While standard formulations dominate, niche markets for organic or additive-free versions can sustain higher price points.
References
[1] IQVIA. (2022). Market data for OTC cough and cold products.
[2] FDA. (2022). OTC Drug monograph updates.
[3] Pharmaceutical Commerce. (2023). API supply chain trends.
