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 |
|---|---|---|---|---|---|---|
| CVS Gentle Laxative | BISACODYL | CVS Pharmacy | 0cca1516-fc8d-4471-bd37-a6230fd225e2 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Gentle Laxative | BISACODYL | RITE AID PHARMACY | 0fb853db-8d97-64d6-e063-6294a90abeb5 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fb8f488-3386-29b9-e063-6294a90a014c | 2026-01-14 | Warnings | M007 |
| Rite-Aid Childrens Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fbe4dfd-1d5d-fc31-e063-6394a90ab317 | 2026-01-14 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 92659389-c36f-499b-b284-5b520e50e9a6 | 2026-01-14 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | AVPAK | af75d33f-b081-4b9d-bc12-d2829fa1f0cf | 2026-01-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | 597d2e9c-1adb-4c7d-ada3-de5c2db69c74 | 2026-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Mineral oil Laxative | MINERAL OIL | Strategic Sourcing Services LLC | ea6da66c-6825-4cd7-8791-45b537bf203a | 2026-01-08 | Warnings | M007 |
| Sunmark Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 06720229-7d58-499e-b7de-cb4bda5ae416 | 2026-01-08 | Warnings | M007 |
| HealthMart Mineral Oil Single Laxative | MINERAL OIL | Strategic Sourcing Services LLC | 1238ec69-1ea3-4773-9f13-71f0ae0a3553 | 2026-01-08 | Warnings | M007 |
| HealthMart Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 689228de-1f3e-4205-853d-6004d6248857 | 2026-01-08 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | c445864f-fc88-4885-9f40-d189b9dc4290 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | c46a1f7c-12e3-4be1-b9e4-d3edac0f4386 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 44fe6ce0-5fed-418f-8a6a-d6132e288328 | 2026-01-07 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Strategic Sourcing Services LLC | 24e29f00-f1cf-4e92-bd67-3f6f820af783 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 33000a06-e030-433a-8f9c-7ae5c08037fa | 2026-01-06 | Warnings | M007 |
| Stool Softener Regular Strength | DOCUSATE SODIUM | Sam's West, Inc | 1eca5910-b0bf-4e07-8211-36dba52b3de7 | 2026-01-06 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Major Pharmaceuticals | c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5 | 2026-01-05 | Warnings | M007 |
| GeriCare Sorbitol Solution | SORBITOL | GERI-CARE PHARMACEUTICALS, CORP | b4dd7a41-380e-d94b-e053-2a95a90ac34a | 2025-12-31 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c | 2025-12-31 | 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 |