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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health, 110 dba Leader | d27dc1cc-5e17-40d3-84fe-c1792552cfd5 | 2026-08-25 | Warnings, Adverse reactions | M007 |
| HyVee Senna S | DOCUSATE SODIUM, SENNOSIDES | HyVee Inc | 4982b9c6-ed0e-24da-e063-6394a90a147f | 2026-08-24 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ccec364a-3135-4a5d-b4b0-86b832387b4e | 2026-08-24 | Warnings | M007 |
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | a1591da0-a1a9-9583-3cf5-788b8fee3814 | 2026-08-24 | M007 | |
| MiraFAST soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 2cee67dd-b71f-32b8-e063-6394a90ae864 | 2026-08-21 | Warnings | M007 |
| HyVee Senna S | DOCUSATE SODIUM, SENNOSIDES | HyVee Inc | 49837b2c-492f-2fed-e063-6294a90aaa24 | 2026-08-21 | Warnings | M007 |
| Senokot-S | STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | c24cdc5e-62e0-41a6-8afb-512202a569f4 | 2026-08-21 | Warnings | M007 |
| Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool Softener | DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG | Strategic Sourcing Services LLC | 5966ff80-7be2-788a-e063-6294a90ab4f3 | 2026-08-19 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | d22fb02f-09c4-476a-b6d6-d3a2fd30049d | 2026-08-18 | Warnings | M007 |
| Fibercon | CALCIUM POLYCARBOPHIL | Medtech Products Inc. | 59534afd-fe38-818a-e063-6394a90a21ea | 2026-08-18 | Warnings | M007 |
| CVS Stool Softener Fruit Punch | DOCUSATE SODIUM | CVS PHARMACY, INC | 0e6900d6-7dc9-47d6-a006-1695feb8d5a5 | 2026-08-17 | Warnings | M007 |
| CVS Senna Laxative | SENNOSIDES | CVS PHARMACY | 5a5565b2-827f-4fcc-a835-d827f62da8f9 | 2026-08-17 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 306fd12b-ed60-40dc-a5be-2dc394bd29d2 | 2026-08-17 | Warnings | M007 |
| CVS Health Childrens Saline Laxative | MAGNESIUM HYDROXIDE | CVS PHARMACY,INC. | e57e5529-2190-4c66-8397-bc2848739e59 | 2026-08-14 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | Morepen Bio Inc | 562d1b9a-09d8-92fc-e063-6394a90a1993 | 2026-08-14 | Warnings | M007 |
| CVS Health | NATURAL FIBER SUPPLEMENT | CVS Pharmacy,Inc. | 04dbe9aa-ed18-4d76-a840-d010445a8643 | 2026-08-14 | Warnings | M007 |
| CVS Fiber Therapy | METHYLCELLULOSE | CVS PHARMACY | e066f5bd-5f34-4e04-beec-3c7d6db49381 | 2026-08-13 | Warnings | M007 |
| Mineral oil | MINERAL OIL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 92f2147d-b52d-4282-b217-28f6095dca0e | 2026-08-12 | Warnings | M007 |
| CAREONE Orange Flavored | PSYLLIUM HUSK | FOODHOLD USA | 4b1cccd2-e941-4d51-9924-4ca35e3a4429 | 2026-08-11 | Warnings | M007 |
| CAREONE | PSYLLIUM HUSK | FOODHOLD USA | 3ec3ead0-382e-4765-bbe8-b21e7c7b42a6 | 2026-08-11 | 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 |