Last updated: March 15, 2026
What is the drug associated with NDC 61269-0165?
NDC 61269-0165 corresponds to Dextromethorphan Hydrobromide, 30 mg/10 mL oral solution. It is classified as an over-the-counter (OTC) cough suppressant used to treat cough associated with minor throat and bronchial irritation.
Market Overview
Current Market Size
- Estimated US OTC cough & cold products market: $3.8 billion (2022, Statista).
- OTC cough suppressants accounted for roughly 15% of combined OTC cold and cough product sales.
- Dextromethorphan (DXM) represents the dominant active ingredient in OTC cough suppressants, with approximately 85% market share within this category.
Competitive Landscape
- Major competitors include brands like Robitussin DM, Vicks DayQuil, and Mucinex DM.
- The market is fragmented among several OTC brands, with private-label products holding approximately 20-25% of sales.
- Recent entrants include formulations with combined ingredients (e.g., DXM + guaifenesin) targeting multi-symptom relief.
Regulatory Status
- The drug is marketed as OTC under the Dietary Supplement Health and Education Act (DSHEA, 1994).
- No current new drug applications (NDAs) or supplemental NDAs required for OTC status.
- Emerging concern over abuse potential (e.g., DXM misuse), prompting potential regulatory scrutiny.
Price Analysis
Current Pricing Trends
- Typical retail small-bottle OTC DXM solutions (e.g., 4 oz/120 mL): $4-$8.
- Wholesale acquisition cost (WAC) for 10 mL doses: approximately $0.50-$1.50 per unit.
- Brand-name products are priced 20-50% higher than private label equivalents.
Price Drivers
- Packaging size and formulation (liquid, syrup, extended-release).
- Brand recognition and perceived efficacy.
- Regulatory and safety considerations influencing marketing.
Cost Analysis
- Manufacturing costs are low, primarily driven by active ingredient price and excipients.
- Estimated production cost: $0.10-$0.20 per 10 mL dose.
- Margins vary but typically range from 30-50% at retail level.
Future Market and Price Projections
Market Growth Forecast (Next 5 Years)
| Year |
Estimated Market Size (USD Billions) |
CAGR |
Notes |
| 2023 |
3.8 |
- |
Baseline |
| 2024 |
4.0 |
5.3% |
Anticipated growth driven by OTC demand |
| 2025 |
4.2 |
5.0% |
Continued expansion |
| 2026 |
4.5 |
7.1% |
Increased consumer health awareness |
| 2027 |
4.8 |
6.7% |
New product formulations introduced |
Price Projections
- Wholesale prices are likely to remain stable or decrease slightly due to market competition.
- Retail prices could rise modestly 1-2% annually driven by inflation and formulation innovation.
- Potential regulation to limit abuse could increase costs related to monitoring and packaging, impacting retail prices.
Impact of Regulatory Changes
- Increased restrictions on DXM sales or sales limits could reduce market volume by 10-15%.
- Strict age restrictions could shift market to more specialized channels, possibly increasing the retail price premium.
Strategic Implications
- Expanding formulation variety (e.g., extended-release, combination therapy) could command higher prices.
- Private-label brands could leverage lower production costs for competitive pricing.
- Regulatory oversight and abuse deterrent measures may challenge market growth but could also open opportunities for branded, abuse-resistant formulations.
Key Factors to Watch
- Regulatory policies addressing DXM misuse.
- Consumer shift toward natural or multi-symptom OTC products.
- Innovation in delivery formats (e.g., dissolvable strips, tablet forms).
Key Takeaways
- The OTC market for DXM-based cough suppressants remains stable with steady growth projections.
- Retail prices are expected to rise modestly in response to product innovations and regulatory pressure.
- Most supply chain costs are minimal, with profit margins driven largely by brand positioning and marketing.
- Regulatory environment, especially abuse potential control measures, will influence future market size and pricing strategies.
- Competitive pricing will pressure margins, with private-label brands gaining market share.
FAQs
Q1: How does regulatory scrutiny threaten the future market for NDC 61269-0165?
Potential restrictions on sales, dosage limits, or age restrictions could decrease volume, impacting revenue.
Q2: Are there opportunities for premium pricing?
Yes, formulations with abuse-deterrent properties or combined ingredients could command higher retail prices.
Q3: How does private label impact the market?
Private-label brands lower retail prices, capturing significant shelf space and reducing brand dominance.
Q4: What are the emerging trends in packaging?
Single-dose packets, dissolvable strips, and extended-release formulations are gaining popularity.
Q5: What is the long-term outlook for OTC DXM products?
Continued demand with moderate growth expected, tempered by regulatory risks and market saturation.
References
[1] Statista. (2022). OTC Cold and Cough Market Size.
[2] U.S. Food and Drug Administration. (2021). OTC monograph on Dextromethorphan.
[3] Grand View Research. (2023). OTC Cold and Cough Products Market Analysis.
[4] U.S. Government Accountability Office. (2020). OTC Cough Suppressant Abuse Potential.
[5] IBISWorld. (2023). Cold & Cough Products in the US.
