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 |
|---|---|---|---|---|---|---|
| up and up fiber therapy | PSYLLIUM HUSK | Target Corporation | 674753ee-1174-4c06-9ed3-a090b338a39e | 2025-11-05 | Warnings | M007 |
| up and up fiber therapy | PSYLLIUM HUSK | TARGET CORPORATION | 956c48f8-c705-4a86-9866-c68a48ddeb6c | 2025-11-05 | Warnings | M007 |
| CEO-TWO | LAXATIVE | Beutlich Pharmaceuticals, LLC | 08670636-5795-4db0-e063-6294a90afa4b | 2025-11-05 | Warnings | M007 |
| up and up gentle laxative | BISACODYL | Target Corporation | 4a29dc2b-b68f-471b-a84e-4a5096aa3748 | 2025-11-04 | Warnings | M007 |
| Target Fiber Laxative | PSYLLIUM HUSK | TARGET CORPORATION | a581116a-392d-4ac3-ae15-4318506a7b2a | 2025-11-04 | Warnings | M007 |
| up and up fiber therapy | CALCIUM POLYCARBOPHIL | Target Corporation. | e5473950-06f4-4ea4-975b-3ac94957e776 | 2025-11-04 | Warnings | M007 |
| up and up fiber therapy Natural Fiber | PSYLLIUM HUSK | Target Corporation | f8b1c831-6fd0-4a58-9726-4e0f986c8084 | 2025-11-04 | Warnings | M007 |
| OneLAX | BISACODYL | AKRON PHARMA INC | be4eeb4d-df29-45dc-94ff-933e52c8b6f6 | 2025-11-03 | Warnings | M007 |
| Gentle Stool Softener | DOCUSATE SODIUM | WALGREEN COMPANY | 169b33f9-e559-47bf-bbba-c7eda4762c7f | 2025-10-31 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Walgreens | 765bfd9b-7a21-4315-9add-cf13007722d5 | 2025-10-31 | Warnings | M007 |
| Gentle Stool Softener | DOCUSATE SODIUM | WALGREEN COMPANY | 71b15339-2585-4fae-8445-6fbb4f0a378e | 2025-10-31 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | 97561cd4-63d9-44c2-a3a3-ec668a09a4ed | 2025-10-31 | Warnings | M007 |
| Fiber Caplets | CALCIUM POLYCARBOPHIL | SAFEWAY | 08e2e8b0-90b3-48d6-a72a-40688c74771a | 2025-10-29 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Marketing Association Inc. | 424d91f0-ecf9-6d9b-e063-6394a90a8006 | 2025-10-29 | Warnings | M007 |
| Publix Laxative Maximum Strength | CALCIUM SENNOSIDES | PUBLIX SUPER MARKETS, INC | 11112859-ef1e-4b37-9915-ba4d06a3f198 | 2025-10-28 | Warnings | M007 |
| Publix Stimulant Laxative | BISACODYL | PUBLIX SUPER MARKETS, INC | 02e596a7-b8e5-4f55-9bc6-6d17e0fabda7 | 2025-10-28 | Warnings | M007 |
| PUBLIX | PSYLLIUM HUSK | PUBLIX SUPER MARKETS, INC | 55f98d3f-f282-4f19-b373-0b59640d274d | 2025-10-28 | Warnings | M007 |
| PUBLIX | CALCIUM POLYCARBOPHIL | PUBLIX SUPER MARKETS, INC | 02e3f4ce-8961-425c-98a9-3b9d66709ca5 | 2025-10-28 | Warnings | M007 |
| Publix Women Laxative | BISACODYL | PUBLIX SUPER MARKETS, INC | 03eeca55-f239-4a01-a900-c1943f27a834 | 2025-10-28 | Warnings | M007 |
| Publix Fiber Therapy Orange Smooth | PSYLLIUM HUSK | PUBLIX SUPER MARKETS, INC | b9c54c20-cd82-4627-9217-a66834db4799 | 2025-10-28 | 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 |