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 |
|---|---|---|---|---|---|---|
| Stratuscare Glycerin Laxative Pediatric | GLYCERIN | Stratus Pharmaceuticals | 6ae6d3c4-bb3b-4436-b76d-8654bf871e66 | 2024-11-01 | Warnings | M007 |
| Rite Aid Fiber Therapy | METHYLCELLULOSE | RITE AID CORPORATION | e50cea80-c020-4b85-b61f-d053f11f479b | 2024-10-30 | Warnings | M007 |
| Rite Aid Fiber Caplets | CALCIUM POLYCARBOPHIL | RITE AID CORPORATION | 06e46cb0-2928-479e-984d-2305fff995e0 | 2024-10-30 | Warnings | M007 |
| Premier Value Orange Flavor | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 2d580965-2bef-46ee-8532-fbe34330a4b4 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy | METHYLCELLULOSE | PHARMACY VALUE ALLIANCE, LLC | b875d5f8-02f3-4474-9fda-83091bc7de04 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy Original Coarse | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 8c85a13d-ae99-4599-9a28-c3965caa6376 | 2024-10-28 | Warnings | M007 |
| Premier Value | CALCIUM POLYCARBOPHIL | PHARMACY VALUE ALLIANCE, LLC | 4d766548-00d0-41bd-bb58-b69e037c77e2 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber | PSYLLIUM HUSK | Chain Drug Consortium, LLC | c507fe4a-1f8e-4780-a2f5-9da6e5922bef | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy Orange Flavor | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 85651bd7-e959-4455-a5ed-bd0223ce0563 | 2024-10-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM AND SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c61c71-9a23-4bd3-e053-2a95a90ad460 | 2024-10-26 | Warnings | M007 |
| Pedia-Lax | GLYCERIN | C.B. Fleet Company, Inc. | ae367381-7146-4307-823d-2bb44c1d4200 | 2024-10-25 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | f7309f4a-f1f5-420e-bfc7-fb4495a5afba | 2024-10-24 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | 2540ae39-2218-0f6a-e063-6294a90a5efc | 2024-10-24 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | Sam's West Inc | b0e99ebb-41fc-459f-86d2-f0e3527f97b0 | 2024-10-24 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | A-S Medication Solutions | ef05ad45-7082-43e6-9533-a79c5aa0f373 | 2024-10-22 | Warnings | M007 |
| Bliss GVS Children | GLYCERIN | Bliss GVS Pharma Limited | 03237ed2-265f-4acd-b504-d82b9263287c | 2024-10-17 | Warnings | M007 |
| NATURAL Epsom Salt | MAGNESIUM SULFATE | Universal Distribution Center LLC | b2682e51-ffa4-4556-b2a6-b0dbd543fd4f | 2024-10-16 | Warnings | M007 |
| Bliss GVS | GLYCERIN | Bliss GVS Pharma Limited | 1a3982a1-9ce9-4a1a-ba73-ebe2d8647109 | 2024-10-10 | Warnings | M007 |
| Bisacodyl | BISACODYL | Padagis US LLC | 7eada0fc-5f83-43da-a56f-b0f537298208 | 2024-10-10 | Warnings | M007 |
| exchange select stool softener | DOCUSATE SODIUM | Army & Air Force Exchange Service | 14985848-d791-42b9-ad7e-810a85bb1ee1 | 2024-10-07 | 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 |