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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | 9019ae9e-da3e-4ed1-b83e-d9a6375e9c30 | 2025-11-25 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Family Dollar (FAMILY WELLNESS) | d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c | 2025-11-25 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM AND SENNOSIDES | Marlex Pharmaceuticals Inc | 9c87759f-3856-4f30-b5ea-4b37ed90f18c | 2025-11-21 | Warnings | M007 |
| Sennosides | SENNOSIDES | Marlex Pharmaceuticals Inc | 5ca287a3-c4f6-402d-978e-cd1328bdbc47 | 2025-11-21 | Warnings | M007 |
| SAMS WEST | PSYLLIUM HUSK | SAM'S WEST INC | 2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac0 | 2025-11-20 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | Geri-Care Pharmaceuticals, Corp | bb47ad1f-251c-491e-8ddd-6f6f719efa15 | 2025-11-20 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 440a96bb-9e68-bdcc-e063-6294a90a6793 | 2025-11-20 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 4277b174-4ce5-4950-8e9b-75e3c019a8f3 | 2025-11-20 | Warnings | M007 |
| Fleet | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC | C.B. Fleet Company, Inc. | c1677d70-203b-493e-88f0-815a66133f1d | 2025-11-20 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | FAMILY DOLLAR SERVICES INC | 5ea9237a-7895-388d-e053-2991aa0a92b0 | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | FAMILY DOLLAR SERVICES INC | 5ea9305b-2997-49d3-e053-2991aa0a1fa1 | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | CVS | 3c8f5b69-56f2-4e9d-e054-00144ff88e88 | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | CVS | 3cdf1975-2607-14f5-e054-00144ff8d46c | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | RITE AID PHARMACY | 60284706-445f-f795-e053-2a91aa0a0a12 | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | Geri-Care Pharmaceuticals, Corp | 9f588e9b-56c5-4426-89fc-7b83e2d0ad1a | 2025-11-19 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Fact Products | aebbdd10-0650-6efe-e053-2a95a90a0ab2 | 2025-11-19 | Warnings | M007 |
| Stool Softener with Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | P & L Development, LLC | 0cbe3b61-ce35-4be1-9caf-9c61fce10ca2 | 2025-11-17 | Warnings | M007 |
| good sense stool softener | DOCUSATE SODIUM | L. Perrigo Company | 4658d162-6e62-4d84-b5d6-7bf16c915558 | 2025-11-14 | Warnings | M007 |
| Topco Fiber Therapy Sugar Free | PSYLLIUM HUSK | TOPCO ASSOCIATES LLC | 2c61e73e-b3f7-4ab2-8bda-e65a2c0b3560 | 2025-11-10 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | LEADER/ Cardinal Health 110, Inc. | b4637e18-c65f-0e81-e053-2a95a90a2284 | 2025-11-06 | 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 |