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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Sam's West, Inc | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 2026-02-03 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | cb2698b1-6c58-417f-ae86-74fbe3814626 | 2026-02-03 | Warnings | M007 |
| Castor Oil | CASTOR OIL | CVS Pharmacy, Inc. | f20de8f2-3637-4485-8b80-0a12fd5e651c | 2026-02-02 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 1dca8f4a-f544-4ae5-bb0a-8b671d4a488a | 2026-02-02 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 15a9996d-7391-41f8-ab15-27ee2a6a60e4 | 2026-02-02 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Rite Aid Corporation | e562bf42-b9e1-4ea8-b880-7bec4dd620b4 | 2026-01-30 | Warnings, Adverse reactions | M007 |
| SENNA-S | DOCUSATE SODIUM AND SENNOSIDES | Strategic Sourcing Services, LLC | 905bd658-a0af-4f20-be3d-00c54868a26c | 2026-01-29 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Strategic Sourcing Services LLC | 9248a907-a8bd-47d5-98a2-48534d6023d4 | 2026-01-29 | Warnings | M007 |
| Leader Castor Oil | CASTOR OIL | Cardinal Health, 110 dba Leader | 49e3a40a-b717-43f6-abed-473d7ed03c2e | 2026-01-29 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | CARDINAL HEALTH 110, LLC. DBA LEADER | 803f444f-d136-4f06-9842-24a71a3d7d6b | 2026-01-29 | Warnings, Adverse reactions | M007 |
| Equate Ready-to-Use Enema Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | WalMart | 04c7440e-5b25-4b63-9604-321298d51021 | 2026-01-29 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Meijer Distribution Inc. | 81edf0d8-b6f3-4b3a-85db-0108160756b1 | 2026-01-28 | Warnings | M007 |
| Quality Choice Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Chain Drug Marketing Association | 1cac3b6b-155b-47bb-bb79-17c55d345736 | 2026-01-28 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1ad73079-ebb3-dae7-e063-6294a90a0558 | 2026-01-28 | Warnings | M007 |
| DOCUSATE SODIUM 100MG | DOCUSATE SODIUM 100MG | Farmacias De Similares TX LLC | 44269b79-a5ad-f443-e063-6294a90a8473 | 2026-01-28 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 19830f9a-27b1-910d-e063-6294a90adace | 2026-01-27 | Warnings | M007 |
| Sennosides | SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 94936bd4-8bbf-6211-e053-2995a90a2138 | 2026-01-27 | M007 | |
| Sennosides | SENNOSIDES | Softgel Healthcare Pvt Ltd | 16582306-7321-6c7c-e063-6394a90a509e | 2026-01-27 | Warnings | M007 |
| Vegetable Laxative | SENNOSIDES | Wal-Mart Stores Inc | 97695092-1ded-4723-a015-fdadd7c28c81 | 2026-01-27 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | CVS Pharmacy, Inc | c3de1c1b-5042-aec3-e053-2a95a90ad134 | 2026-01-27 | 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 |