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 |
|---|---|---|---|---|---|---|
| Signature Care | CASTOR | Better Living Brands, LLC | 4947cf4d-3ebd-4b66-9582-f141407aa300 | 2026-06-15 | Warnings, Adverse reactions | M007 |
| WALGREEN GLYCERIN ADULT | GLYCERIN SUPPOSITORY | Walgreens | 20c44346-0b29-7364-e063-6294a90a648f | 2026-06-15 | Warnings | M007 |
| WALGREENS GLYCERIN | GLYCERIN SUSPENSION | Walgreens | 20c44346-0b2b-7364-e063-6294a90a648f | 2026-06-15 | Warnings | M007 |
| Stratuscare Bisacodyl | BISACODYL | Stratus Pharmaceuticals | 795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d | 2026-06-09 | Warnings | M007 |
| Laxative | LAXATIVE | Allegiant Health | 596b11de-cf17-4c55-8638-49f387e5fac4 | 2026-06-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | 16691fd4-cdf3-41d4-b851-5fa148a05468 | 2026-06-08 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Cardinal Health 107, LLC | 144c7242-4ff9-404a-86bf-48e2871eb0cd | 2026-06-05 | Warnings | M007 |
| Senna Natural Vegetable | SENNOSIDES | Medline Industries, LP | 9a6240f3-398c-06b8-e053-2995a90a73df | 2026-06-04 | Warnings | M007 |
| Senna S | SENNOSIDES AND DOCUSATE SODIUM | Medline Industries, LP | 6cd22881-db60-9045-e053-2991aa0ae08a | 2026-06-04 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | NuCare Pharmaceuticals, Inc. | 53727f3a-914c-0e2c-e063-6394a90a3886 | 2026-06-04 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Geri-Care Pharmaceuticals, Corp | 99eb67ca-301c-dfdb-e053-2a95a90aff6f | 2026-05-28 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | CVS PHARMACY, INC | 1f9e72dc-a394-420d-8fe8-fc4d0f6906ed | 2026-05-27 | Warnings | M007 |
| Walgreens Adult Glycerin Laxative | GLYCERIN SUPPOSITORY | Walgreens | 5285403b-ab44-21a1-e063-6394a90a9fd0 | 2026-05-23 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | 9983095a-6ef4-4ad7-acc5-e34221fb7c63 | 2026-05-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS PHARMACY, INC | 056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138 | 2026-05-20 | Warnings | M007 |
| Senna Syrup | SENNOSIDES 8.8MG/5ML | Aldama Pharmaceuticals, Inc | 491255c6-465f-a78a-e063-6394a90aa408 | 2026-05-15 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES AND DOCUSATE SODIUM | Cardinal Health 107, LLC | 40385b89-a855-4ca2-992a-df5eb677be15 | 2026-05-15 | Warnings | M007 |
| Docusate Sodium - Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | cc8d1556-f108-4166-837c-48f81152877e | 2026-05-12 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | GOODSENSE | a9509715-cc4f-595d-e053-2a95a90ae31f | 2026-05-11 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | ee14dfe2-405f-493a-a774-ce1b01d05dd4 | 2026-05-05 | 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 |