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 |
|---|---|---|---|---|---|---|
| Milk of Magnesia mint | MAGNESIUM HYDROXIDE | Meijer, Inc. | bb8ba371-f53c-1088-e053-2a95a90a4cbf | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | STRATEGIC SOURCING SERVICES LLC | 00c61622-367b-0a5b-e063-6294a90a6706 | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Strategic Sourcing Services LLC | 003a3c0d-7a48-e44d-e063-6394a90a3f4a | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Geri-Care Pharmaceuticals, Corp | 2d1be236-e136-4727-a52d-714f62880088 | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d690d82-e4fb-57ad-e053-2a91aa0a38ea | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d6a8048-93e7-42e5-e053-2991aa0acabd | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d7f5a38-4222-5bfb-e053-2991aa0a17e3 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | CARDINAL HEALTH | af4b6b64-97c9-a794-e053-2a95a90aaf0b | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | CARDINAL HEALTH | af5ddf5d-b1f5-2918-e053-2995a90a2d61 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | H E B | ab998776-6b30-9f17-e053-2995a90a96cd | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | H E B | abfe89c8-86f1-bd1e-e053-2995a90af773 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | GOODSENSE | a951617d-c6fa-75e0-e053-2995a90afcf8 | 2023-11-07 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | KROGER COMPANY | a1b04366-ff67-3bb3-e053-2a95a90a816c | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | BETTER LIVING BRANDS, LLC | b9440381-df40-4bc7-e053-2995a90ae83f | 2023-11-07 | Warnings | M007 |
| Milk of Magnesia mint | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83f6027-51a0-1730-e053-2995a90a553b | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83eb807-d522-4408-e053-2a95a90a7926 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83f0c1c-0e90-2888-e053-2995a90a0b96 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | DOLGENCORP, INC. | b6991abf-9819-701c-e053-2a95a90ac0b4 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 7722145c-913c-4ed5-a9b2-a6c343064066 | 2023-11-06 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 12361478-d178-4950-9458-4e2e56565599 | 2023-11-06 | 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 |