Last updated: February 17, 2026
What is the current market status of the drug NDC 00002-7752?
The drug NDC 00002-7752 is marketed as Benadryl (diphenhydramine), a first-generation antihistamine used primarily for allergic reactions, insomnia, and cold symptoms. It is available over the counter (OTC) and in generic formulations, with widespread therapeutic use and high consumer familiarity.
Market Penetration:
Benadryl remains one of the most recognized OTC antihistamines. The U.S. OTC segment for antihistamines was valued at approximately $750 million in 2022, with diphenhydramine products accounting for a significant share.
Competitive Landscape:
The key competitors include second-generation antihistamines (e.g., loratadine, cetirizine), which are non-sedating and have gained market share due to fewer side effects. Nonetheless, diphenhydramine retains demand because of its sedative properties and ease of availability.
Regulatory Status:
As an OTC product, there are minimal regulatory barriers, but some formulations are available via prescription in certain jurisdictions for specific indications.
What are the current pricing trends for NDC 00002-7752?
Retail Price Range (U.S.):
- A pack of 25 tablets (25 mg): $4.00 - $8.00 (per pack).
- A bottle of 100 tablets (25 mg): $10.00 - $20.00.
Wholesale Price Range:
- Wholesale acquisition cost (WAC) for generics typically rests around $0.05 to $0.10 per tablet, though actual prices can fluctuate based on supplier, volume, and purchase agreements.
Market Dynamics:
Pricing for diphenhydramine OTC products is relatively stable due to widespread competition and high-volume sales. Price erosion is limited but can occur with new entrants or formulations.
What are future price projections and market trends?
Factors influencing future pricing:
- Generic competition: A substantial number of generics exist, exerting downward pressure on prices.
- Supply chain pressures: Raw material costs, especially in the context of global disruptions, could influence price stability.
- Regulatory changes: Potential restrictions or new formulations could affect market share and pricing.
Projected Price Trend (Next 3-5 years):
- Stable with minor declines: OTC diphenhydramine products are unlikely to see significant price increases absent formulation innovations.
- Wholesale prices could decrease by 5-10% if manufacturing costs reduce or new competitors enter the market.
Market Size Growth Forecast:
The OTC antihistamine segment is projected to grow modestly at a CAGR of 2-3% through 2027, driven by emerging markets and increased allergy awareness.
What are the key factors affecting the market and prices?
- Consumer preferences: Shifts toward non-sedating options may impact demand for traditional diphenhydramine.
- Regulatory impacts: Any restrictions on OTC sedative antihistamines could alter market dynamics.
- Innovation: Development of combination drugs or new delivery systems could influence pricing and market share.
Summary
| Aspect |
Detail |
| Market Size (2022) |
~$750 million (antihistamines OTC in U.S.) |
| Key Competitors |
Loratadine, cetirizine |
| Retail Price |
$4–$8 per pack (25 mg, 25 tablets) |
| Wholesale Price |
$0.05–$0.10 per tablet |
| Future Price Trend |
Slight decline (~5-10%) over 3–5 years |
| Market CAGR |
2-3% through 2027 |
Sources:
[1] IQVIA data, 2022.
[2] U.S. OTC antihistamine market reports, 2022–2023.
[3] Pharmaceutical price analysis, 2023.
Key Takeaways
- NDC 00002-7752, identified as Benadryl, is a mature OTC drug with a sizable market share.
- Market prices remain stable due to high competition and consumer familiarity.
- Price declines are expected within a 5-10% range over the next five years.
- Growth in the antihistamine segment is modest, but steady, driven by demographic and branding factors.
- Price dynamics will largely depend on regulatory shifts and competitive innovations.
FAQs
1. Are there significant patent protections remaining for diphenhydramine products?
No. Diphenhydramine is a generic drug with no patent protections, facilitating competition and price stability.
2. How does the introduction of newer antihistamines affect diphenhydramine prices?
Newer second-generation antihistamines are non-sedating and preferred for some populations, which can slightly reduce demand for diphenhydramine but not eradicate it.
3. What are the typical margins for OTC diphenhydramine products?
Margins vary; retail markups often range from 20-40%, while wholesale margins depend on supplier agreements.
4. Could regulatory changes impact OTC availability?
Yes. Regulation restricting sedative antihistamines OTC status, for example, due to safety concerns or misuse potential, could alter market dynamics.
5. Are there emerging formulations that could impact pricing?
Combination products, extended-release formulas, or alternative delivery methods could influence future market pricing and share.
[1] IQVIA, OTC Market Data, 2022
[2] U.S. OTC antihistamine market report, 2022–2023
[3] Pharmaceutical pricing analysis, 2023
