Last updated: August 5, 2025
Introduction
The drug identified by National Drug Code (NDC): 00555-0171, currently marketed as McNeil Consumer Healthcare’s Tylenol Extra Strength (acetaminophen), occupies a significant segment within over-the-counter (OTC) analgesics. Its broad usage for pain relief and fever reduction propels sustained demand, influencing market dynamics, pricing strategies, and future trajectory. This analysis examines the current market landscape, factors affecting price trends, competitive positioning, and forecasts future pricing pathways.
Product Overview
NDC 00555-0171 is a widely distributed OTC medication containing 500 mg of acetaminophen per tablet, primarily used for mild to moderate pain and antipyretic purposes. As a flagship product in Tylenol’s portfolio, it benefits from brand recognition, regulatory approval, and widespread retail distribution.
Market Landscape
Market Size and Demand Dynamics
The OTC analgesics market remains robust, driven by consumers seeking low-cost, effective pain management options. According to data from IQVIA and Statista, the US OTC analgesics market exceeded USD 9 billion in 2022, with acetaminophen products constituting a substantial share due to their safety profile and regulatory approval (market share approximating 40-50%).
Demand for acetaminophen has been consistently resilient, with seasonal fluctuations during flu and cold seasons, and an increasing trend toward self-medication. The COVID-19 pandemic further amplified demand for OTC analgesics, underscoring their essential role in consumer health.
Regulatory Influences
Regulatory considerations, notably the FDA’s ongoing safety reviews related to hepatotoxicity risks associated with acetaminophen, influence market dynamics. In 2014, the FDA recommended lowering the maximum daily dose to 3,000 mg to mitigate liver injury risks, prompting formulary adjustments among manufacturers and healthcare providers. Ongoing safety assessments may further impact labeling, marketing, and pricing.
Competitive Dynamics
The competitive landscape includes:
- Brand-name products: Tylenol (McNeil), with significant market share, benefitting from consumer trust and brand loyalty.
- Private-label OTCs: Retailers’ store brands often price 15-25% lower, gaining consumer traction.
- Other analgesics: NSAIDs like ibuprofen (Advil, Motrin) and naproxen (Aleve) provide alternatives, often competitive on price and efficacy.
Despite generic availability, Tylenol maintains premium positioning owing to brand recognition and perceived safety.
Pricing Analysis
Current Price Points
Retail price points for NDC 00555-0171 vary across channels:
- Pharmacy and OTC Retailers: Typical retail price per package (100 tablets of 500 mg) ranges from USD 5.49 to USD 8.99.
- Wholesale/Distributor Pricing: Generally lower by 20-30%, translating into more considerable margins for retailers.
- Private Label Variants: Often priced 20-30% below branded versions, impacting the market share of branded Tylenol.
Pricing Trends
Over the past five years, retail prices have remained relatively stable, with minor fluctuations attributable to inflation, supply chain factors, and regulatory updates. During the COVID-19 pandemic, some shortages and supply chain disruptions temporarily drove prices upward by approximately 10-15%, but these increases normalized by late 2021.
Impact of Regulatory Changes
The FDA’s dose-limitation recommendations and safety communications have prompted some formulary and marketing adjustments, with potential pressure on pricing:
- Formulations with lower acetaminophen doses or combination products may command higher per-unit prices.
- Enhanced safety labeling, while necessary, increases production costs, marginally impacting pricing.
Market Trends and Future Price Projections
Key Factors Influencing Future Pricing
- Regulatory Environment: Persistent safety concerns may accelerate moves toward lower-dose formulations or reformulations, impacting manufacturing costs and pricing.
- Consumer Preferences: Growing preference for "clean-label" and safer OTC options could favor established brands like Tylenol, supporting premium pricing.
- Supply Chain Dynamics: Persistent supply chain disruptions, especially post-pandemic, could keep short-term prices elevated or lead to shortages, temporarily increasing retail prices.
- Competitive Market Entry: The introduction of affordable generics and private-label versions exerts downward pressure, but brand loyalty sustains premium pricing.
- Pricing Innovation: Manufacturers may explore value-added formulations or packaged offerings, influencing price points.
Price Projection (Next 3-5 Years)
Based on current trends, the following projections are anticipated:
- Stability with Marginal Inflation: Retail prices are expected to remain within the USD 5.49 - USD 8.99 range for standard packages, with annual inflation-adjusted increases of approximately 2-3%.
- Potential for Premiumization: Introduction of formulations with added safety features or combination therapies may command higher prices, potentially increasing retail costs by 5-8%.
- Price Fluctuations During Supply Disruptions: Short-term price spikes of 10-15% could recur during supply shortages, similar to pandemic-era fluctuations.
Overall, the market offers stable pricing with gradual inflationary growth, tempered by competition and regulatory shifts.
Concluding Perspectives
NDC 00555-0171 remains a cornerstone in OTC analgesic markets. Its pricing stability is anchored by strong brand presence, consumer trust, and regulatory positioning. While external factors—such as safety advisories and supply chain conditions—pose occasional perturbations, the long-term outlook points toward modest, steady price increases aligned with inflation and value addition.
Key Takeaways
- The OTC acetaminophen market is robust, with Tylenol maintaining a strong position due to brand equity.
- Retail prices for NDC 00555-0171 are stable, averaging USD 5.49 to USD 8.99 per 100-tablet pack, with slight upward pressure expected over the next few years.
- Regulatory safety communications influence formulation and labeling, potentially affecting cost structures and pricing strategies.
- Competitive pressures from generics and private labels limit significant price hikes but leave room for premium formulations.
- Supply chain disruptions, especially post-pandemic, can cause short-term price volatility, but long-term trends favor stability with gradual growth.
FAQs
1. How will regulatory safety concerns impact the pricing of Tylenol (NDC: 00555-0171)?
Regulatory safety concerns, primarily regarding hepatotoxicity risks, may lead to formulation changes, lower dose recommendations, or additional safety warnings. These adjustments can increase manufacturing costs or influence consumer perception, potentially leading to slight price increases. However, significant price hikes are unlikely unless supply disruptions occur.
2. What is the competitive outlook for branded Tylenol compared to private-label OTCs?
While private-label OTCs offer lower prices and capture part of the market share, Tylenol benefits from strong brand loyalty, perceived safety, and consistent efficacy. This positions Tylenol to maintain premium pricing, although price sensitivity among consumers supports competitiveness.
3. Are there any upcoming innovations that could influence prices?
Innovations such as combination formulations, lower-dose variants with enhanced safety features, or novel delivery methods could create premium offerings, allowing manufacturers to command higher prices. However, widespread adoption depends on regulatory approvals and consumer acceptance.
4. How has the COVID-19 pandemic affected the pricing and availability of this drug?
Pandemic-related supply chain disruptions caused temporary shortages, leading to price fluctuations of approximately 10-15% in some markets. These fluctuations have largely stabilized, but ongoing supply chain considerations may continue to influence pricing marginally.
5. What are the risk factors that could alter the market price trajectory?
Key risks include stricter regulatory restrictions, safety concerns prompting reformulation, supply shortages, and increased competition from generic and private-label products. Economic factors affecting consumer spending can also impact purchasing patterns and pricing strategies.
References
[1] IQVIA. (2022). United States OTC Analgesics Market Report.
[2] Statista. (2022). Share of Acetaminophen in OTC Analgesics Market.
[3] FDA. (2014). Acetaminophen Hepatotoxicity Risk and Regulatory Recommendations.
[4] McNeil Consumer Healthcare. Product information and pricing data.
[5] MarketWatch. (2023). OTC Analgesics Industry Trends.
