Overview
Bismuth subsalicylate is an antacid and anti-diarrheal agent. Exhibiting antibacterial and gastroprotective properties, bismuth subsalicylate is an insoluble salt of salicylic acid linked to trivalent bismuth cation. Each molecule of bismuth subsalicylate contains 58% bismuth and 42% salicylate by weight. Bismuth subsalicylate has been around for over 100 years: it was originally developed in 1901 for hygienic use and sanitation for cholera infection. Bismuth subsalicylate was first approved by the FDA in 1939 and is now mainly used to relieve nausea, diarrhea, and gastrointestinal discomfort. It is an active ingredient found in Pepto-Bismol, a common over-the-counter medication that is used to temporarily treat discomforts of the stomach and gastrointestinal tract. Bismuth subsalicylate is a component of HELIDAC Therapy (bismuth subsalicylate, metronidazole, and tetracycline), which is a treatment regimen indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease.
Indication
Bismuth subsalicylate is indicated to temporarily relieve diarrhea, travelers' diarrhea, and upset stomach due to overindulgence in food and drink, including heartburn, indigestion, nausea, gas, belching, and fullness. Bismuth subsalicylate is a component of HELIDAC Therapy (bismuth subsalicylate, metronidazole, and tetracycline), which is a treatment regimen indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease.
Associated Conditions
- Diarrhea
- Dyspepsia
- Flatulence
- Heartburn
- Helicobacter Pylori Infection
- Nausea
- Traveler's Diarrhea
- Upset stomach
- Belching
- Gastrointestinal fullness
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/07/05 | Phase 1 | Completed | |||
2018/11/29 | Phase 4 | Completed | Fatih Sultan Mehmet Training and Research Hospital | ||
2018/07/19 | Phase 4 | Withdrawn | |||
2018/05/24 | Phase 3 | Terminated | |||
2014/01/28 | Not Applicable | Completed | |||
2012/12/05 | Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine | ||
2004/06/10 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kramer Laboratories | 55505-198 | ORAL | 262 mg in 15 mL | 4/17/2025 | |
| Walgreens | 0363-0025 | ORAL | 525 mg in 30 mL | 5/7/2025 | |
| Kramer Laboratories | 55505-206 | ORAL | 262 mg in 1 1 | 4/17/2025 | |
| Safecor Health, LLC | 48433-127 | ORAL | 262 mg in 1 1 | 6/7/2025 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-1286 | ORAL | 525 mg in 30 mL | 5/12/2025 | |
| Procter & Gamble Manufactura S de RL de CV | 58933-002 | ORAL | 262 mg in 1 1 | 3/19/2025 | |
| Kramer Laboratories | 55505-197 | ORAL | 262 mg in 1 1 | 4/17/2025 | |
| Best Choice (Valu Merchandisers Company) | 63941-736 | ORAL | 525 mg in 30 mL | 6/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bismuth Subsalicylate Dispersible Tablets | 国药准字H20041438 | 化学药品 | 片剂 | 6/22/2020 | |
| Bismuth Subsalicylate Dispersible Tablets | 国药准字H20070207 | 化学药品 | 片剂 | 6/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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