Womens Gentle Laxative
- Product NDC
- 36800-676
- 11-digit product format
- 368000676
- Labeler code
- 36800
- Product ID
- 36800-676_c14a3300-5d83-4773-9464-4af192b7d318
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bisacodyl
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- part334
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2019-05-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 36800-676 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 36800-676 | 36800-676-01 | D | Discontinued by firm | 2026-10-16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-676-01 | 36800067601 | 2 BLISTER PACK in 1 CARTON (36800-676-01) > 15 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2019-05-01 | 0000-00-00 | No | No | Current |