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 | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f4671579-aed0-4f93-ab83-248e0d72b5b0 | 2026-08-10 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | Aldama Pharmaceuticals, Inc | 492b6d37-47cf-3a28-e063-6294a90a2a18 | 2026-08-10 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Safeway Inc | 0b757160-f9eb-4413-9b43-97544c49c72f | 2026-08-10 | Warnings, Adverse reactions | M007 |
| Bisacodyl Laxative | BISACODYL | InvaDerm Corporation | 58ba9a9f-98d8-c380-e063-6294a90a774c | 2026-08-10 | Warnings | M007 |
| Sennosides | SENNOSIDES | Cardinal Health 107, LLC | 4a9e1cbe-ffe4-462f-a86d-078a357dcf49 | 2026-08-07 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Shield Pharmaceuticals Corp | 0be906d8-3db5-4218-bbdf-f1d126007990 | 2026-08-07 | Warnings | M007 |
| MiraFAST KIDS soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 58636827-239d-cc63-e063-6294a90a6180 | 2026-08-06 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 4e97dd60-96e3-4b51-b614-c62480af1919 | 2026-08-06 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | 098d2377-0019-45fe-b995-700b1b1241c4 | 2026-08-05 | Warnings | M007 |
| Docusate Sodium softgels 50mg (Dye Free) | DOCUSATE SODIUM | CVS Pharmacy | 273ea95f-3c9c-98e8-e063-6294a90a2135 | 2026-08-05 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Old East Main Co. | 4bae831d-caba-40c9-bdb5-2611eac35dd5 | 2026-08-05 | Warnings, Adverse reactions | M007 |
| Metamucil Therapy for regularity | PSYLLIUM HUSK | Atlantic Biologicals Corp. | 57b112ea-f6b1-baa6-e063-6394a90a3b29 | 2026-08-05 | Warnings | M007 |
| WinCo Pure 5lb | PURE 5LB EPSOM SALT | WinCo Foods, LLC | 58529382-a192-cda2-e063-6394a90adb69 | 2026-08-05 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | cbb0edf4-1fa7-42f5-a6f7-027e3961b50a | 2026-08-05 | Warnings | M007 |
| Sennosides | SENNOSIDES | LEADER/ Cardinal Health 110, Inc. | e3c7ece8-82f3-cd0c-e053-2995a90ad800 | 2026-08-04 | Warnings | M007 |
| CVS Glycerin | GLYCERIN SUPPOISITORY | CVS Pharmacy, Inc | ca6d13db-60e8-4fcc-b7b3-3eb280b8c435 | 2026-08-04 | Warnings | M007 |
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | 7793fced-e8ee-44e2-b212-dd2a59a5f462 | 2026-08-04 | Warnings | M007 |
| Dual Action Senna Stool Softener | DOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MG | Shield Pharmaceuticals Corp | a04435df-aace-497f-a3a8-d8e8489db661 | 2026-08-03 | Warnings | M007 |
| Docusate Sodium - Stool Softener Laxative | DOCUSATE SODIUM | Cardinal Health 107, LLC | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 2026-07-28 | Warnings | M007 |
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | 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 |