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 |
|---|---|---|---|---|---|---|
| Mineral Oil | MINERAL OIL | United Natural Foods, Inc. dba UNFI | cb7bc571-295f-47c2-ae93-18cba194752c | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Strategic Sourcing Services LLC | e4965086-dcc0-4b34-bb30-81facf7139f3 | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Valu Merchandisers Company | cd3e5836-b2f0-41f3-8623-3105c4642491 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Valu Merchandisers Company | a693f6b0-0679-4609-9ca0-dddfa4158c02 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Valu Merchandisers Company | fb358bc3-e479-42e7-8aea-a6a3676f2430 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Valu Merchandisers Company | ff539c1c-9ed3-49be-9b30-1858f12e1e90 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | United Natural Foods, Inc. dba UNFI | bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Walgreens SmoothLAX Soft Chews | MAGNESIUM HYDROXIDE | Walgreens | 424e27ce-0b11-9cd2-e063-6294a90a3c21 | 2026-02-16 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | da013c15-3531-4dc5-b122-bfc99bc494ae | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | db1bc651-1a35-4f92-a917-c6a19f421594 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b | 2026-02-13 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | b2ec06b3-647d-49ab-a392-6db63d96d1e3 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Topco Associates LLC | 5643f2e0-93e2-4c2e-90a0-fd152150d18a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Topco Associates LLC | d3cc7cb6-098e-413c-b1ad-7ebf5fa35269 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Topco Associates LLC | bc89c4bc-5207-479d-9a3b-e570b412a7ba | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | 72f69aa0-381a-4e5c-975d-3a73fdc1b377 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Topco Associates LLC | e9b1fd61-c229-4529-82c2-d6ac5b076082 | 2026-02-13 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Pinnacle RX LLC | 4abbb0e4-e005-bc4e-e063-6394a90a126a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| 365 Whole Foods Market Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market, Inc. | 4147cdd0-57f6-3857-e063-6394a90afecb | 2026-02-12 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Your Military Exchanges | 27cff497-123c-424a-9c43-57740c00168b | 2026-02-12 | Warnings, Adverse reactions | 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 |