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 |
|---|---|---|---|---|---|---|
| Womens Gentle Laxative | BISACODYL | BETTER LIVING BRANDS LLC. | f2c4ed1a-5aa4-1915-e053-2a95a90a59b6 | 2025-02-12 | Warnings | M007 |
| Laxative | SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c5c1e6-3123-c802-e053-2995a90aa073 | 2025-02-12 | Warnings | M007 |
| Vegetable Laxative | SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c529e4-6738-377c-e053-2995a90aaf38 | 2025-02-12 | Warnings | M007 |
| WOMENS GENTLE LAXATIVE | BISACODYL | CVS HEALTH CORP | a95073f3-e1d6-d291-e053-2a95a90aefea | 2025-02-12 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE | SENNOSIDES | CVS HEALTH | b05ee52f-4801-d4ca-e053-2995a90af348 | 2025-02-12 | Warnings | M007 |
| SENNA | SENNOSIDES | Reliable 1 Laboratories LLC | c8aa7ae9-7d00-db7d-e053-2995a90ae72b | 2025-02-11 | Warnings | M007 |
| Extra Gentle Laxative | BISACODYL | DOLGENCORP INC | be214c4e-f6db-cc8d-e053-2a95a90addf7 | 2025-02-10 | Warnings | M007 |
| SENNA-S | DOCUSATE SODIUM AND SENNOSIDES | KROGER | a187045c-c9d6-592a-e053-2995a90adb83 | 2025-02-10 | Warnings | M007 |
| SENNA TIME | SENNOSIDES | TIME CAP LABORATORIES, INC | 18ec8127-422c-4c1a-8331-58dabce69969 | 2025-02-08 | Warnings | M007 |
| SENNA TIME S | DOCUSATE SODIUM-SENNOSIDES | TIME CAP LABORATORIES, INC | dc491692-8d3a-4ccd-a17d-4c630f122595 | 2025-02-08 | Warnings | M007 |
| LAX-TIME | SENNOSIDES | TIME CAP LABORATORIES, INC | 74a627fc-00e5-eb78-e053-2991aa0abacc | 2025-02-08 | Warnings | M007 |
| SENNOSIDES AND DOCUSATE SODIUM | SENNOSIDES AND DOCUSATE SODIUM | TIME CAP LABORATORIES, INC | 0ad617e0-10a6-44fa-be62-4f3cc725fb01 | 2025-02-08 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Asclemed USA, Inc. | 2db546de-20dc-4697-aff2-12471f073b1d | 2025-02-08 | Warnings | M007 |
| SENNOSIDES | SENNOSIDES | TIME CAP LABORATORIES, INC | 7498f5fa-1739-bb6e-e053-2a91aa0a5404 | 2025-02-07 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | WALMART INC. | 26b9f247-c242-2925-e063-6394a90a68dd | 2025-02-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | PAI Holdings, LLC dba PAI Pharma | e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5 | 2025-02-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | PD-Rx Pharmaceuticals, Inc. | 6a7e4193-22d2-491e-9842-5c43f571fc65 | 2025-02-05 | Warnings | M007 |
| Mineral oil | MINERAL OIL | Best Choice (Valu Merchandisers Company) | 3ec8a716-60e0-4dfb-adae-ddc53c613935 | 2025-02-04 | Warnings | M007 |
| DOCUSATE SODIUM 50MG SOFTGEL (RED) | DOCUSATE SODIUM | CVS Pharmacy | 273e5b52-1cf9-2525-e063-6394a90a8b4f | 2025-02-04 | Warnings | M007 |
| Laxative | SENNOSIDES | WALGREENS | f0caba1d-0c09-8496-e053-2995a90a47cf | 2025-01-30 | 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 |