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 Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | eb7f3d65-8741-407d-b3f3-1d9dda19684d | 2024-03-05 | Warnings | M007 |
| Fleet | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC | C.B. Fleet Company, Inc. | f50ba829-16c3-40a7-9822-8d6d00353b33 | 2024-02-29 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 4ce62421-97e0-4920-9a6d-9fa1f0f93fe4 | 2024-02-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 851a5dda-e72b-4067-a98f-54d3222f646e | 2024-02-23 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | BJWC (Berkley & Jensen / BJ's) | 2ca80e23-f38a-4f77-b536-131cc9f0cf5b | 2024-02-23 | Warnings | M007 |
| Colon Detox | DOCUSATE SODIUM AND SENNOSIDES | OPMX LLC | 0a4d3265-080c-d2ed-e063-6394a90adbee | 2024-02-21 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | Best Choice (Valu Merchandisers Company) | 4501d718-15a7-4e27-bdb1-8aa2d3ff06d0 | 2024-02-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Best Choice (Valu Merchandisers Company) | 72bd251b-4e82-41ef-8362-39f95faf9916 | 2024-02-15 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON | CARDINAL HEALTH, INC. 063997360 | 10bdd5e6-3db2-8f9e-e063-6394a90a9b3f | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | CARDINAL HEALTH, INC. 063997360 | 10beb3ec-a189-221d-e063-6394a90aabb5 | 2024-02-06 | Warnings | M007 |
| Magnesium Citrate | LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | CARDINAL HEALTH, INC. 063997360 | 10bebb63-19b3-2e14-e063-6394a90a8d4e | 2024-02-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Proficient Rx LP | f9ac0344-5864-4ac1-81bc-16878a5946c5 | 2024-02-01 | Warnings | M007 |
| Purifi Hand Sanitizer | BENZALKONIUM CHLORIDE | Purifi LLC | 9267069d-4cf5-4e48-a446-7dbebea16bf5 | 2024-01-31 | Warnings | M007 |
| WOMENS LAXATIVE ENTERIC COATED | BISACODYL | CARDINAL HEALTH | ab34bc89-6738-d284-e053-2a95a90a5dc9 | 2024-01-11 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE | SENNOSIDES | CARDINAL HEALTH | b7b13bfa-8a94-6f62-e053-2995a90abbf4 | 2024-01-10 | Warnings | M007 |
| FIBER LAXATIVE | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | e4a921c5-1cf7-12ca-e053-2a95a90a6e04 | 2024-01-03 | Warnings | M007 |
| Freskaro Castor Oil | CASTOR OIL | Pharma Nobis, LLC | fbd6bdd5-a7a1-3f28-e053-6294a90aab87 | 2023-12-28 | Warnings | M007 |
| Humco Castor Oil | CASTOR OIL | Pharma Nobis, LLC | e42f9d37-1b07-177a-e053-2a95a90a9b06 | 2023-12-26 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Pharma Nobis, LLC | f0477328-eca1-9043-e053-2995a90aaa3d | 2023-12-22 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Pharma Nobis, LLC | f0489f6f-9e60-7d69-e053-2a95a90a9dfb | 2023-12-22 | 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 |