Stool Softener
- Product NDC
- 57896-401
- 11-digit product format
- 578960401
- Labeler code
- 57896
- Product ID
- 57896-401_08173bad-d29e-d916-e063-6394a90a609f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceutical Corp
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2000-01-01
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-10 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-01 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-25 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 57896-401-03 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-10 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-01 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-25 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 57896-401-03 | 110d247fa046… | a55b01930146… |
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
- Stool Softener
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115005 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 644d81ec-d38f-4172-a087-727b94e2fefe | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 57896-401-01 | 2020-09-29 | gc 401 |
| 57896-401-03 | 2020-09-29 | gc 401 |
| 57896-401-10 | 2020-09-29 | gc 401 |
| 57896-401-25 | 2020-09-29 | gc 401 |
| 57896-401-01 | 2019-11-27 | gc 401 |
| 57896-401-03 | 2019-11-27 | gc 401 |
| 57896-401-10 | 2019-11-27 | gc 401 |
| 57896-401-25 | 2019-11-27 | gc 401 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-401-01 | Stool Softener | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 4 | |
| 57896-401-03 | Stool Softener | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 4 | |
| 57896-401-10 | Stool Softener | 1000 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 1000 | 4 | |
| 57896-401-20 | Stool Softener | 200 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 200 | 4 | |
| 57896-401-25 | Stool Softener | 250 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 250 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-401-01 | EA - Each | 57896-401 | da8e6844-b6ae-4244-8bfc-f7ad99d8eaf8 | 1 | 2013-06-04 |
| 57896-401-03 | EA - Each | 57896-401 | 6762957d-d7f6-4213-a664-2c7f42fc9f36 | 1 | 2013-06-04 |
| 57896-401-10 | EA - Each | 57896-401 | 7ae1d03c-6162-4398-b8d2-1946db28e941 | 1 | 2013-06-04 |
| 57896-401-20 | EA - Each | 57896-401 | 8f701acd-94d7-43d2-9072-f8fbf72510af | 1 | 2021-02-05 |
| 57896-401-25 | EA - Each | 57896-401 | 5c82cab7-f225-43ff-b3f5-38f5ffd4b01a | 1 | 2018-11-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Senna-S | DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG | Walgreens | 36cc3a5b-1891-d39e-e063-6294a90a93b4 | 2025-12-31 | Warnings | M007 |
| Senna Liquid | SENNOSIDES | RUGBY LABORATORIES | 8123b092-2ae9-459b-ae06-6ceb837adcf8 | 2025-12-30 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM | RUGBY LABORATORIES | e21d19d8-6c2d-4474-a663-dfe7e91ac320 | 2025-12-30 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | RUGBY LABORATORIES | b1bafa6e-0f54-1c35-e053-2995a90a42e4 | 2025-12-30 | Warnings | M007 |
| OneLAX SENNA | SENNA | ATLANTIC BIOLOGICALS CORP. | d2a5a13a-e7e4-488a-b60b-4dd467efa971 | 2025-12-29 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | Llorens Pharmaceutical International Division, Inc. | 5be0163c-b7f7-46db-b738-78c2946a6cf6 | 2025-12-29 | Warnings | M007 |
| Senokot | STANDARDIZED SENNA CONCENTRATE | Atlantis Consumer Healthcare, Inc. | c18dd7fa-993b-440b-8cdd-f1551abb99ca | 2025-12-29 | Warnings | M007 |
| LAXATIVE | BISACODYL | GRAXCELL PHARMACEUTICAL, LLC | 5a65d4ab-447f-42bb-b38d-070db523b806 | 2025-12-25 | Warnings | M007 |
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Pharbest Pharmaceuticals, Inc. | 2b5152b2-d354-409f-a19f-b470f4181b3f | 2025-12-24 | Warnings | M007 |
| Senna Tabs | SENNA | Pharbest Pharmaceuticals, Inc. | b9f8ea59-932f-4827-a87c-b4aff909c43f | 2025-12-24 | Warnings | M007 |
| Senna Plus | DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG | CARDINAL HEALTH, 110 DBA LEADER | 4d4101ca-7d78-4712-9b3d-f395f2646c6b | 2025-12-23 | Warnings | M007 |
| Equate Gentle Laxative Soft chew | MAGNESIUM HYDROXIDE | Walmart | 0997c1b7-16db-7db7-e063-6294a90a5928 | 2025-12-23 | Warnings | M007 |
| Equate Kids Gentle Laxative SC | MAGNESIUM HYDROXIDE | Walmart | 1662a542-aef0-9087-e063-6294a90aa6d9 | 2025-12-23 | Warnings | M007 |
| AMAZON FIBER CAPLETS | CALCIUM POLYCARBOPHIL | AMAZON.COM SERVICES LLC | 178f4150-c75c-45e1-a5f3-3af67b5c8109 | 2025-12-22 | Warnings | M007 |
| AMAZON FIBER THERAPY | METHYLCELLULOSE | AMAZON.COM SERVICES LLC | 3eee7b21-5401-4ef1-b1c6-1013439639d2 | 2025-12-22 | Warnings | M007 |
| Sennosides | SENNOSIDES | Granules USA Inc | a619b8f4-1b5d-181b-e053-2995a90ab729 | 2025-12-22 | Warnings | M007 |
| CAREALL Sennosides | SENNOSIDES | New World Imports, Inc | 61bbbb6a-9997-4df1-94be-a80686d1f1b9 | 2025-12-22 | Warnings | M007 |
| Walgreens Blueberry Raspberry Gentle Laxative | MAGNESIUM HYDROXIDE | Walgreen | d35f1518-bc63-83eb-e053-2995a90ae4bb | 2025-12-21 | Warnings | M007 |
| Sennosides | SENNOSIDES | Walgreens Co | 85a2f7ed-315e-2403-e053-2991aa0abdce | 2025-12-19 | Warnings | M007 |
| Sennosides | SENNOSIDES | H E B | a5652d5b-43fd-5bfa-e053-2995a90aad6c | 2025-12-19 | Warnings | M007 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57896-401-01 | 57896040101 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-01) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-03 | 57896040103 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-03) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-10 | 57896040110 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-10) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-20 | 57896040120 | 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-20) | 2020-09-01 | 0000-00-00 | No | No | Current |
| 57896-401-25 | 57896040125 | 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (57896-401-25) | 2020-09-20 | 0000-00-00 | No | No | Current |