stimulant laxative
- Product NDC
- 69452-541
- 11-digit product format
- 694520541
- Labeler code
- 69452
- Product ID
- 69452-541_4b1f7db3-c6a9-7f6a-e063-6394a90a5829
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- bisacodyl
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- BIONPHARMA INC.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-23
- 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
- stimulant laxative
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BISACODYL | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 10X0709Y6I | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308753 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4b1f7db3-c6a8-7f6a-e063-6394a90a5829 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69452-541-83 | stimulant laxative | 300 in 1 BOTTLE | TABLET, DELAYED RELEASE | 300 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Cardinal Health 107, LLC | 1a21b07a-263c-41a4-ba0c-ad2dc5a295d7 | 2026-05-05 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 4842a767-bb12-9d85-e063-6294a90a19b5 | 2026-04-27 | Warnings | M007 |
| Alcohol wet wipes | ALCOHOL WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f79dbac0-cec0-46bc-e053-6294a90a2b13 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f7ca1799-eee4-66f0-e053-6294a90a273f | 2026-04-25 | Warnings | M007 |
| Wet wipes | WET WIPES | JINGXIN GROUP (M) SDN BHD | 395225b1-486b-1867-e063-6394a90a1865 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | JINGXIN GROUP (M) SDN BHD | 3952873e-5e3f-1bff-e063-6294a90a8a62 | 2026-04-25 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Publix Supermarkets, Inc. | ed50555f-b105-45c8-9dc4-1bd4d233a1e3 | 2026-04-23 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Publix Supermarkets, Inc. | 382a57d1-85bf-480f-9967-f85da2904410 | 2026-04-23 | Warnings | M007 |
| BISACODYL | BISACODYL | AARNA USA INC. | 50109967-69af-5fc5-e063-6394a90a8751 | 2026-04-22 | Warnings | M007 |
| Senna | SENNA | Rugby Laboratories | 41d53783-7ac2-411c-b9bf-afd87b3af30d | 2026-04-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | 95bae7bf-f240-4674-9e3c-640a603fdc35 | 2026-04-15 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | a4b442f1-d5a6-4cbf-b371-1f6639634f80 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | 267c434d-3034-491b-b4b1-1d0cbacb1615 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | d616685a-11fc-4ae0-80de-7d25c0d71ee9 | 2026-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 84116db2-a7b7-460a-a5e5-8558bd424781 | 2026-04-02 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | American Health Packaging | 7d7d789b-b2e7-4600-a025-0cd2ff5b3672 | 2026-04-02 | Warnings | M007 |
| Castor Oil | CASTOR OIL | STRATEGIC SOURCING SERVICES | 4db6736f-416a-f142-e063-6394a90ab08f | 2026-04-01 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Farmacias De Similares TX LLC | 4e6a64a0-e453-709b-e063-6294a90a7443 | 2026-04-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | 93ef6486-0930-41e3-a2c6-44af7e37e98b | 2026-03-31 | Warnings | M007 |
| Senna Syrup | NATURAL VEGETABLE LAXATIVE | Bryant Ranch Prepack | 2c0d62e7-563b-46e4-9793-183e98e761a6 | 2026-03-25 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308753 | bisacodyl 5 MG Delayed Release Oral Tablet | PSN | 4b1f7db3-c6a8-7f6a-e063-6394a90a5829 | 1 |
| 308753 | bisacodyl 5 MG Delayed Release Oral Tablet | SCD | 4b1f7db3-c6a8-7f6a-e063-6394a90a5829 | 1 |
| 308753 | bisacodyl 5 MG Enteric Coated Oral Tablet | SY | 4b1f7db3-c6a8-7f6a-e063-6394a90a5829 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69452-541-83 | 69452054183 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-541-83) | 2026-02-23 | No | No | Current |