NDAORALTABLET, CHEWABLE, TABLET, CAPSULE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
HELIDAC (bismuth subsalicylate; metronidazole; tetracycline hydrochloride) by R-Pharm US. Approved for travelers' diarrhea diarrhea upset stomach due to overindulgence in food, drink, including: heartburn indigestion nausea gas belching fullness. First approved in 1996.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIDAC is a fixed-dose combination oral tablet containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride, approved in 1996 for treatment of travelers' diarrhea and gastrointestinal upset including heartburn, indigestion, nausea, and gas. The three-component formulation works synergistically to address multiple GI symptoms through antimicrobial and antacid mechanisms. This is a mature, off-patent product in the over-the-counter and prescription gastrointestinal market.
LOE Approaching
This product is transitioning toward loss of exclusivity, suggesting that commercial teams are likely focused on legacy brand maintenance and cost-efficiency rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.