Gentle Laxative
- Product NDC
- 36800-327
- 11-digit product format
- 368000327
- Labeler code
- 36800
- Product ID
- 36800-327_56e2e24b-debc-43ca-b385-745360a7ae41
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bisacodyl
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates, LLC
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-05-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gentle Laxative
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISACODYL | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 10X0709Y6I |
| Rxcui | 308753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-327-03 | Gentle Laxative | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 11 |
| 36800-327-03 | Gentle Laxative | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 11 |
| 36800-327-56 | Gentle Laxative | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 11 |
| 36800-327-56 | Gentle Laxative | 25 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 25 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-327 | GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES, LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250323_e4ff1277-b859-4c34-872f-0dc5b7879121.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-327-03 | 36800032703 | 1 BLISTER PACK in 1 CARTON (36800-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-05-15 | 0000-00-00 | No | No | Current |
| 36800-327-56 | 36800032756 | 1 BLISTER PACK in 1 CARTON (36800-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-05-15 | 0000-00-00 | No | No | Current |