Docusate Sodium and Sennosides
- Product NDC
- 35916-0454
- 11-digit product format
- 359160454
- Labeler code
- 35916
- Product ID
- 35916-0454_47db8971-4012-5504-e063-6294a90afd37
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium and Sennosides
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-06-22
- Substance
- SENNOSIDES; DOCUSATE SODIUM
- Active strength
- 8.6; 50 mg/1; mg/1
- 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
- Docusate Sodium and Sennosides
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SENNOSIDES | 8.6 mg/1 |
| DOCUSATE SODIUM | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FYP5M0IJX | Internal UNII lookup |
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1791612 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ad73079-ebb3-dae7-e063-6294a90a0558 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0454-1 | Docusate Sodium and Sennosides | 500 in 1 BOTTLE | CAPSULE, GELATIN COATED | 500 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0454 | DOCUSATE SODIUM AND SENNOSIDES CAPSULE, GELATIN COATED [SOFTGEL HEALTHCARE PVT LTD] | 1 | Current NDC, 1 package rows | 20240623_1ad73079-ebb3-dae7-e063-6294a90a0558.zip |
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 |
|---|---|---|---|---|---|---|
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 5999904a-6ac8-4d9e-951c-6e64e8cd93eb | 2023-11-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e98f9d9-679c-63a2-e053-2991aa0a4b8d | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e957b01-4f44-0a2a-e053-2991aa0a37a0 | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e993b13-8dc8-6653-e053-2a91aa0a4c2a | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | CVS | 3c8e4144-6702-2678-e054-00144ff88e88 | 2023-10-31 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | 9d22c208-d089-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | a0e6ab9b-fd31-45fd-93d5-b51d705c180a | 2023-10-27 | Warnings | M007 |
| Sennosides Natural Laxative | SENNOSIDES | Magno-Humphries, Inc. | 9d22bedb-9fca-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | 9d22d642-8aed-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Magno-Humphries, Inc. | 9deaf264-6af0-40ba-e053-2a95a90ada0e | 2023-10-27 | Warnings | M007 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | 2528cb5e-437e-41f0-9c34-e9ce57404d8b | 2023-10-26 | Warnings | M007 |
| Magnesium Citrate | MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Major Pharmaceuticals | 088e5543-c947-af78-e063-6294a90a8bc4 | 2023-10-25 | Warnings | M007 |
| DOK | DOCUSATE SODIUM | MAJOR PHARMACEUTICALS | 7a92070d-98cc-662f-e053-2991aa0aa1b2 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | KROGER COMPANY | a1afaa71-7e8c-5a49-e053-2a95a90a4db0 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Asclemed USA, Inc. | 30fc8c07-c26b-4bcc-a727-6e193f5727fd | 2023-10-16 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | MEIJER, INC. | e43bd2ed-17c7-4530-af72-81a7ad70069c | 2023-10-12 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Care One (Retail Business Services, LLC.) | 9adaec97-43e3-48f2-96c8-c508b693676c | 2023-10-05 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | TopCo Associates, LLC | 83aeb90a-ab00-4e26-aa44-5259dce59018 | 2021-04-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 9fbe783e-ddd9-445a-852a-00f4ad754880 | 2021-04-20 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1791612 | sennosides 8.6 MG / docusate sodium 50 MG Oral Capsule | PSN | 1ad73079-ebb3-dae7-e063-6294a90a0558 | 2 |
| 1791612 | docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Capsule | SCD | 1ad73079-ebb3-dae7-e063-6294a90a0558 | 2 |
| 1791612 | DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Capsule | SY | 1ad73079-ebb3-dae7-e063-6294a90a0558 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 35916-0454-1 | 35916045401 | 500 CAPSULE, GELATIN COATED in 1 BOTTLE (35916-0454-1) | 2024-06-22 | No | No | Current |