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 |
|---|---|---|---|---|---|---|
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Preferred Pharmaceuticals Inc. | f8bba8cb-a111-4285-8bdb-2273a049c3bb | 2026-07-08 | Warnings | M007 |
| DOCUSATE SODIUM, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2026-07-06 | Warnings | M007 |
| Curewell Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | RMT HEALTH LLC | 55903043-2a1d-0525-e063-6394a90ae182 | 2026-07-01 | Warnings | M007 |
| Senna | SENNOSIDES 8.6 MG TABLETS | Aarkish Pharmaceuticals NJ Inc. | 564bc9a5-13b5-4cce-a349-6b2e122683ed | 2026-07-01 | Warnings | M007 |
| Senna-S | DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG | Aarkish Pharmaceuticals NJ Inc. | faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f | 2026-07-01 | Warnings | M007 |
| ENEMEEZ | DOCUSATE SODIUM | Quest Products, LLC | 0b06445d-0839-497e-bdff-e0fe224a7738 | 2026-06-30 | Warnings | M007 |
| ENEMEEZ Plus | DOCUSATE SODIUM AND BENZOCAINE | Quest Products, LLC | 1670ca59-7275-4ac6-bef4-674a7b24c7b3 | 2026-06-30 | Warnings | M007 |
| Mineral oil | MINERAL OIL | CVS Pharmacy, Inc. | 1183bcbc-51ec-e53a-e063-6394a90af0f2 | 2026-06-26 | Warnings, Adverse reactions | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552d9018-cc7d-7e1a-e063-6294a90a3322 | 2026-06-26 | Warnings | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552e16b9-f46a-7838-e063-6394a90ab8aa | 2026-06-26 | Warnings | M007 |
| Walgreens Gentle Laxative | BISACODYL SUPPOSITORY | Walgreens | 20c43036-830b-0e1d-e063-6394a90adf5f | 2026-06-25 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | American Health Packaging | be7cab51-ce7e-465d-95db-083e69288cfd | 2026-06-25 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Vi-Jon, LLC | ba490c22-19f0-4887-9509-bd3d32e0f5b1 | 2026-06-24 | Warnings, Adverse reactions | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | KROGER COMPANY | a1b0c638-6c34-1b72-e053-2995a90acc85 | 2026-06-24 | Warnings | M007 |
| Womens Laxative | WOMENS LAXTIVE | Allegiant Health | 549a11d1-a096-4c22-96b4-2d4f54f46022 | 2026-06-24 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Meijer Distribution Inc | f4259fda-19d4-087e-e053-2995a90a7081 | 2026-06-22 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Geri-Care Pharmaceuticals, Corp | 3ec42148-6786-22f2-e054-00144ff8d46c | 2026-06-18 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 546347e5-841e-15ca-e063-6294a90a0c8b | 2026-06-16 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 5463f869-2b92-4551-e063-6394a90ad6f9 | 2026-06-16 | Warnings | M007 |
| MINICA-S | GLYCERIN | Sato Pharmaceutical Co., Ltd. | 687902eb-e702-4e87-a0ce-9add05e3cbc1 | 2026-06-16 | 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 |