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 | United Natural Foods, Inc. dba UNFI | b1d903a5-1d5f-44d4-9939-a4b86e5a620d | 2024-05-23 | Warnings | M007 |
| Senna laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | 30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8 | 2024-05-23 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | MEIJER, INC. | 11fe5bd0-585a-ad8a-e063-6294a90a3ae8 | 2024-05-22 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Sam's West, Inc | b14d2495-1092-4063-869f-73a7e8c28708 | 2024-05-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d | 2024-05-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | c0898583-4bbb-41d5-9e84-00cca823024f | 2024-05-15 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9c986ca8-d540-49c1-b092-94c1bf837c07 | 2024-05-09 | Warnings | M007 |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 381f4179-0c3b-41f8-927c-c88534ebe06d | 2024-05-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | ed20d198-e935-200e-e053-2a95a90a309b | 2024-05-02 | Warnings | M007 |
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Major Pharmaceuticals | 1768b470-2808-fa46-e063-6394a90ac8d9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Stimulant laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9467e1f7-19bb-4fb3-853b-75c4d28bb9a9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | c1e9863a-c229-4694-b450-6b0e0ad37503 | 2024-04-30 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 96c7f8bc-be95-40d1-9977-44b7cc6582df | 2024-04-22 | Warnings | M007 |
| Pedia-Lax | MAGNESIUM HYDROXIDE | C.B. Fleet Company, Inc. | 975f24d8-218c-40f4-84a5-558acf34329d | 2024-04-11 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | H E B | 2f9e2723-53a7-47a8-8c41-87bffc4e50dd | 2024-04-09 | Warnings | M007 |
| Senna | SENNOSIDES | H E B | d047e4e9-b8ac-498e-9fde-8af5d415edaa | 2024-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 5b8bcc6c-de03-4d73-a76f-6f4c371cf250 | 2024-04-09 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | H E B | 1dd2be7e-bdca-4e43-b853-3ed10b636632 | 2024-04-08 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 1f11cf85-b094-4ca4-8b48-2d3a9093304b | 2024-04-04 | 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 |