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 |
|---|---|---|---|---|---|---|
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Pharma Nobis, LLC | f0488c86-6c74-3987-e053-2a95a90a31b4 | 2023-12-22 | Warnings | M007 |
| Mineral Oil Heavy | MINERAL OIL | Pharma Nobis, LLC | e42f6c6d-c4de-02c6-e053-2995a90a3ace | 2023-12-22 | Warnings | M007 |
| Quality Choice Castor Oil | CASTOR OIL | Chain Drug Market Asociation | 18d7124f-7745-45b2-adc4-cb1103add5d6 | 2023-12-20 | Warnings | M007 |
| Premiere Value Castor Oil | CASTOR OIL | Chain Drug Consortium | 5c8c1564-fcff-894b-e053-2991aa0a9c0b | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Bionpharma, Inc. | f0fa4b72-50a5-5c42-e053-2995a90a159a | 2023-12-20 | Warnings | M007 |
| Harris Teeter Castor Oil | CASTOR OIL | Harris Teeter, LLC | 5cca6b4b-d88f-1c7d-e053-2991aa0a051f | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Bionpharma, Inc. | f0f9c36e-c43b-05d2-e053-2995a90a6d65 | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Bionpharma, Inc. | f0f9ff19-ae08-0af0-e053-2a95a90ab842 | 2023-12-20 | Warnings | M007 |
| CVS Mineral Oil | MINERAL OIL | CVS | 9d7402e1-524b-1084-e053-2a95a90ae3af | 2023-12-20 | Warnings | M007 |
| Top Care Castor Oil | CASTOR OIL | TOPCO ASSOCIATES LLC | 8dce1a1f-e765-9c75-e053-2995a90abf9f | 2023-12-18 | Warnings | M007 |
| Humco Epson Salt | MAGNESIUM SULFATE | Humco Holding Group, Inc. | 7a9d1b77-6c39-46f1-86f2-4059dde20f85 | 2023-12-15 | Warnings | M007 |
| Humco Mineral Oil Heavy | MINERAL OIL | Humco Holding Group, Inc. | 9f943fdf-5058-4e18-ba96-6be112bf72ca | 2023-12-15 | Warnings | M007 |
| Rite Aid Castor Oil | CASTOR OIL | Rite Aid Corporation. | 5e0d3664-b01b-ba28-e053-2991aa0a8a4c | 2023-12-15 | Warnings | M007 |
| GNP Castor Oil | CASTOR OIL | Amerisource Bergen | 5d06bec6-f1e7-4f0c-e053-2991aa0a8ad8 | 2023-12-14 | Warnings | M007 |
| Sankaijo | DOCUSATE SODIUM, SENNOSIDES | Sato Pharmaceutical Co., Ltd. | 83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b | 2023-11-29 | Warnings | M007 |
| SIMPEX Bisacodyl laxative | BISACODYL | Simpex Pharma Pvt. Ltd | 5114ed64-4fec-401b-8a91-8df3e42b10b1 | 2023-11-29 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | b595063a-5fee-18c2-e053-2a95a90a5b99 | 2023-11-15 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Publix | cbf7dcef-7623-b333-e053-2a95a90a0f1a | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Meijer, Inc. | bb8b51e9-ba4a-270d-e053-2a95a90a318b | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | STRATEGIC SOURCING SERVICES LLC | ff0d4b9f-7ce8-dd98-e053-6394a90ab614 | 2023-11-08 | 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 |