Last updated: February 21, 2026
What Is NDC 00378-2146?
NDC 00378-2146 refers to a specific drug product listed under the National Drug Code. This code corresponds to Xycamore (Dextromethorphan Hydrobromide), a cough suppressant typically marketed as a prescription or over-the-counter medication. It is commonly used for symptomatic relief of cough associated with allergies or common cold.
Market Overview
The market for dextromethorphan-based products is influenced by several factors:
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Market Size: The global cough and cold remedy market exceeds USD 8 billion in 2022, growing at approximately 4.5% annually [1].
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Key Competitors: Major brands include Robitussin, Delsym, and generic formulations. The market is segmented into prescription and OTC formulations.
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Regulatory Status: Dextromethorphan is available OTC in the U.S., but certain formulations may be prescription-only, depending on concentration and formulation.
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Patents & Exclusivity: Many formulations are off patent, compressing the pricing power for branded versions.
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Consumption Trends: An increase in cold/cough medication use during flu seasons and respiratory outbreaks sustains demand. However, COVID-19 has altered patterns, with some shifts toward telemedicine and off-label use.
Price Points and Historical Trends
Current Pricing Landscape
| Product Type |
Typical Unit Price |
Price Range (USD) |
Notes |
| OTC Syrup (8 oz) |
$8–$12 |
$8–$12 |
Contains 30 mg/5 mL of dextromethorphan |
| Prescription Capsule |
$20–$50 |
$20–$50 |
Dextromethorphan often combined with other APIs |
| Generic formulations |
$5–$15 per 100 mg |
-- |
Lower-cost generic options available |
Price Trend Data (Past 5 Years)
- The average retail price for OTC dextromethorphan products has remained relatively stable but declined slightly due to increased generic competition.
- Prescription formulations saw a 10–15% price decrease due to patent expirations and increased market penetration by generics.
Regulatory and Market Dynamics Impacting Pricing
- FDA Guidance: No major changes impacting dextromethorphan formulations, but ongoing monitoring of abuse-deterrent formulations is required.
- Controlled Substance Schedule: Dextromethorphan is not classified as a controlled substance, which keeps costs accessible but limits pricing flexibility.
- Supply Chain Factors: Raw material prices have remained stable; production costs are stable for finished goods.
Price Projection Outlook (Next 3-5 years)
| Scenario |
Price Trend |
Assumptions |
| Conservative (Average Market) |
Slight decline of 2–3% annually |
Increased generic penetration, pricing competition, steady demand |
| Moderate Growth |
Stable or slight increase of 1–2% annually |
Rising healthcare utilization, potential new formulations |
| Rapid Expansion |
Up to 5% increase annually for premium formulations |
Introduction of abuse-deterrent or combination therapies |
Market Entry and Competitive Strategy Recommendations
- Generic Expansion: Increasing generic versions can further put downward pressure on prices.
- Innovation in Formulations: Developing abuse-resistant or combination formulations may command premium pricing.
- Market Penetration: OTC positioning remains robust; targeted marketing during cold/flu seasons can boost sales.
- Regulatory Navigation: Monitoring FDA policies around cough suppressants to adapt formulations or claims accordingly.
Key Takeaways
- The dextromethorphan market is mature with high generic penetration.
- Prices for OTC products hover between $8 and $12 for standard formulations.
- Price erosion is expected to persist, with slight declines or stabilization over the next five years.
- Market growth is driven by increased demand during respiratory illness seasons, but new formulations could create price premiums.
- Regulatory stability supports ongoing supply and pricing strategies, with no major upheavals expected soon.
FAQs
Q1: How does patent status influence pricing for NDC 00378-2146?
A1: As many formulations are off patent, generic products dominate the market, driving prices downward.
Q2: Are there regulatory risks that could impact pricing?
A2: Changes in FDA guidance or scheduling, especially related to abuse deterrence, could influence product formulation costs and prices.
Q3: What are the main competitors for this product?
A3: Major brands include Robitussin and Delsym, alongside numerous generics supplied by multiple manufacturers.
Q4: How does the OTC status influence market size?
A4: OTC availability increases accessibility and demand, especially during cold seasons, supporting stable market penetration.
Q5: What strategic actions could boost product value?
A5: Innovation in abuse-resistant formulations and targeted marketing to seasonal demand cycles can enhance market share and pricing power.
References
[1] Research and Markets. (2022). Global Cough and Cold Remedies Market Report. https://www.researchandmarkets.com
