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NDC 36800-0327-03 Gentle Laxative 5 mg/1 Details
Gentle Laxative 5 mg/1
Gentle Laxative is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates, LLC. The primary component is BISACODYL.
MedlinePlus Drug Summary
Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 36800-0327-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 36800-0327 |
|---|---|
| Product ID | 36800-327_c6888e5b-7958-4c99-90ca-c5221d9dbbfc |
| Associated GPIs | |
| GCN Sequence Number | 023896 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 200-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53382 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Gentle Laxative |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bisacodyl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISACODYL |
| Labeler Name | Topco Associates, LLC |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | 505G(a)(3) |
| Listing Certified Through | 2024-12-31 |
Package
NDC 36800-0327-03 (36800032703)
| NDC Package Code | 36800-327-03 |
|---|---|
| Billing NDC | 36800032703 |
| Package | 1 BLISTER PACK in 1 CARTON (36800-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2019-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |