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 |
|---|---|---|---|---|---|---|
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Cardinal Health 107, LLC | 1a21b07a-263c-41a4-ba0c-ad2dc5a295d7 | 2026-05-05 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 4842a767-bb12-9d85-e063-6294a90a19b5 | 2026-04-27 | Warnings | M007 |
| Alcohol wet wipes | ALCOHOL WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f79dbac0-cec0-46bc-e053-6294a90a2b13 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f7ca1799-eee4-66f0-e053-6294a90a273f | 2026-04-25 | Warnings | M007 |
| Wet wipes | WET WIPES | JINGXIN GROUP (M) SDN BHD | 395225b1-486b-1867-e063-6394a90a1865 | 2026-04-25 | Warnings | M007 |
| Sterilized wet wipes | STERILIZED WET WIPES | JINGXIN GROUP (M) SDN BHD | 3952873e-5e3f-1bff-e063-6294a90a8a62 | 2026-04-25 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Publix Supermarkets, Inc. | ed50555f-b105-45c8-9dc4-1bd4d233a1e3 | 2026-04-23 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Publix Supermarkets, Inc. | 382a57d1-85bf-480f-9967-f85da2904410 | 2026-04-23 | Warnings | M007 |
| BISACODYL | BISACODYL | AARNA USA INC. | 50109967-69af-5fc5-e063-6394a90a8751 | 2026-04-22 | Warnings | M007 |
| Senna | SENNA | Rugby Laboratories | 41d53783-7ac2-411c-b9bf-afd87b3af30d | 2026-04-18 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | 95bae7bf-f240-4674-9e3c-640a603fdc35 | 2026-04-15 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | a4b442f1-d5a6-4cbf-b371-1f6639634f80 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Publix Super Markets, Inc. | 267c434d-3034-491b-b4b1-1d0cbacb1615 | 2026-04-13 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | d616685a-11fc-4ae0-80de-7d25c0d71ee9 | 2026-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 84116db2-a7b7-460a-a5e5-8558bd424781 | 2026-04-02 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | American Health Packaging | 7d7d789b-b2e7-4600-a025-0cd2ff5b3672 | 2026-04-02 | Warnings | M007 |
| Castor Oil | CASTOR OIL | STRATEGIC SOURCING SERVICES | 4db6736f-416a-f142-e063-6394a90ab08f | 2026-04-01 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Farmacias De Similares TX LLC | 4e6a64a0-e453-709b-e063-6294a90a7443 | 2026-04-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | 93ef6486-0930-41e3-a2c6-44af7e37e98b | 2026-03-31 | Warnings | M007 |
| Senna Syrup | NATURAL VEGETABLE LAXATIVE | Bryant Ranch Prepack | 2c0d62e7-563b-46e4-9793-183e98e761a6 | 2026-03-25 | 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 |