Proctozone-B
- Product NDC
- 57237-372
- 11-digit product format
- 572370372
- Labeler code
- 57237
- Product ID
- 57237-372_d5aaad18-797d-48cd-9ebb-2120207b742f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bisacodyl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-10
- Substance
- BISACODYL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Proctozone-B
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISACODYL | 5 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57237-372-01 | 57237037201 | 100 TABLET, COATED in 1 BOTTLE (57237-372-01) | 2026-10-10 | No | No | Current |