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 |
|---|---|---|---|---|---|---|
| Curewell Senna Syrup | SENNOSIDES | RMT HEALTH LLC | 57345324-5140-5cde-e063-6294a90ab97c | 2026-07-22 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE ORAL SOLUTION | WALGREEN COMPANY | 4ffe54ae-3126-ba58-e063-6294a90a8877 | 2026-07-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | deca083b-5c72-40fa-9021-b74028426a5a | 2026-07-20 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | fc5e82b6-e25c-4686-9781-2205819685f5 | 2026-07-20 | Warnings | M007 |
| Best Choice Fiber Therapy Orange Flavor | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 0b25f6c0-441b-41ef-ab19-2a29705a56c6 | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Therapy original coarse | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d7eb71af-17e3-465e-b464-f77b3be7266d | 2026-07-17 | Warnings | M007 |
| Best Choice | CALCIUM POLYCARBOPHIL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 24eb538f-abcb-4a91-b691-a8aac01c952a | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Laxative | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 92b46689-b5fc-41f4-91ac-535699900b39 | 2026-07-17 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 498acb19-b2f4-4af0-8996-390115c17fe0 | 2026-07-17 | Warnings, Adverse reactions | M007 |
| Best Choice Fiber Therapy | METHYLCELLULOSE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | fab6567f-d988-43f2-a6cf-44e5b24af279 | 2026-07-17 | Warnings | M007 |
| stool softener | DOCUSATE SODIUM | Amazon.com Services LLC | 4f83953e-3779-43b7-a5c6-7442a0675d9b | 2026-07-16 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 183576bd-c252-471b-8797-32cac5b0329c | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Walgreens | 3f9d54d9-a9d5-40ff-a8a2-431997b58999 | 2026-07-16 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 7174021b-bdc0-4fd3-90e7-3904980033c4 | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | ff2179bd-cc76-9ee9-e053-6294a90a01c9 | 2026-07-15 | Warnings | M007 |
| FEVIA Constipation Control | DOCUSATE SODIUM | VIVUNT PHARMA LLC | 4b21ca11-b81f-402c-e063-6394a90a3acb | 2026-07-15 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | 56957a51-7366-f7ed-e063-6294a90abfc5 | 2026-07-14 | Warnings | M007 |
| Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6103fded-622c-4551-9f32-ca1da44683ac | 2026-07-10 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | 800fa966-077d-4624-9e36-75fe8863dad0 | 2026-07-10 | Warnings | M007 |
| SENNA TIME | SENNOSIDES | Bryant Ranch Prepack | bdcf37fc-3938-4d3f-b669-35c6939eac4f | 2026-07-10 | 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 |