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 |
|---|---|---|---|---|---|---|
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Proficient Rx LP | 8678a3ee-0e2c-4c95-ad2e-83aa601f3238 | 2024-10-01 | Warnings | M007 |
| Pedia-Lax | DOCUSATE SODIUM | C.B. Fleet Company, Inc. | 0e908bea-ebab-44e7-919c-90002e6f5d42 | 2024-10-01 | Warnings | M007 |
| Natural Vegetable Laxative and Stool Softener | DOCUSATE SODIUM AND SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c562e1-4080-44cb-e053-2a95a90a4222 | 2024-09-25 | Warnings | M007 |
| SENNA-S LAXATIVE WITH STOOL SOFTENER | SENNOSIDES | Basic Drugs, Inc. | d32b9956-fc04-8d64-e053-2a95a90a17b3 | 2024-09-14 | Warnings | M007 |
| DOCUSATE SODIUM, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | e8be12c5-c591-eadd-e053-2a95a90a431b | 2024-09-13 | Warnings | M007 |
| Senna | SENNOSIDES | Proficient Rx LP | 5f7f0df4-dabe-4c8f-a2b5-766f20af2f46 | 2024-09-01 | Warnings | M007 |
| Fiber caplets 147 | CALCIUM POLYCARBOPHIL | Chain Drug Marketing Association Inc. | 17e2a50d-1867-49fe-e063-6394a90a56df | 2024-08-27 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE PILLS | SENNOSIDES | TARGET CORPORATION | 7cae52ae-931c-3e7c-e053-2991aa0a8396 | 2024-08-22 | Warnings | M007 |
| STOOL SOFTENER AND STIMULANT LAXATIVE | DOCUSATE SODIUM AND SENNOSIDES | TARGET CORPORATION | 7cac99da-8d89-0aee-e053-2991aa0a0fd9 | 2024-08-22 | Warnings | M007 |
| SENNA LAXATIVE | SENNOSIDES 8.6 MG | TARGET CORPORATION | 7cab058f-3647-7124-e053-2a91aa0a41bd | 2024-08-22 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Padagis Israel Pharmaceuticals Ltd | bce3b245-ec47-4e62-9cad-bb12d0812c18 | 2024-08-15 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | 56f7966a-c95e-3ce3-e054-00144ff88e88 | 2024-08-14 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Proficient Rx LP | ccfa095c-77f0-41ff-84f8-e02d983c7c74 | 2024-08-01 | Warnings | M007 |
| Magnesium Citrate | HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Harris Teeter, LLC | 1e8e01fc-2c89-9722-e063-6394a90a6acf | 2024-07-31 | Warnings | M007 |
| Senna laxative | SENNOSIDES | Best Choice (Valu Merchandisers Company) | d5f90aa1-78e5-491f-b09d-399d54f3def1 | 2024-07-31 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Walgreens | db528659-768a-46e0-a340-9fbcdb25ea5e | 2024-07-25 | Warnings | M007 |
| Senna laxative | SENNOSIDES | Walgreens | bfa089a6-4767-45e0-b663-ee7e8949d9a4 | 2024-07-25 | Warnings | M007 |
| Dr. Fibra | PSYLLIUM HUSK | Pharmadel LLC | 1a6151c9-e1c4-f0c1-e063-6394a90aad24 | 2024-07-22 | Warnings | M007 |
| BISACODYL | BISCODYL | TARGET CORPORATION | 8ed281d5-b17e-e3bb-e053-2995a90a2590 | 2024-07-15 | Warnings | M007 |
| Stool Softener | DOCUSATE CALCIUM | Walgreens | b6f0770e-671d-4965-9275-b1c224d7f06a | 2024-07-10 | 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 |