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 |
|---|---|---|---|---|---|---|
| Publix Fiber Therapy Sugar Free | PSYLLIUM HUSK | PUBLIX SUPER MARKETS, INC | ed3dc80a-a243-4013-9886-b148e3e3b662 | 2025-10-28 | Warnings | M007 |
| Childrens Oral Saline Laxative | MAGNESIUM HYDROXIDE | WAL-MART STORES,INC., | a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc | 2025-10-27 | Warnings | M007 |
| equate Fiber Therapy | METHYLCELLULOSE | Wal-Mart Stores,Inc., | 7acc30b4-e946-42cd-8eec-cf15159d478d | 2025-10-27 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | 5e97aa5b-62e2-0664-e053-2a91aa0ac341 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | H E B | 3d03ce42-e671-6d76-e054-00144ff8d46c | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | CVS Pharmacy | c56e010a-7503-3e1c-e053-2a95a90a2b85 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Consortium LLC | 022dd494-cb3c-4fa7-be99-4c38fabdc612 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | 5e97c4d2-e41d-5bb6-e053-2a91aa0a3163 | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Major Pharmaceuticals | c194c40c-c732-2f03-e053-2a95a90a7a40 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | CVS Pharmacy | 94e4a6f3-43d0-b2a5-e053-2a95a90aa115 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Marketing Association Inc. | 5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Rite Aid Corporation | 5da2ea79-f3bc-b82b-e053-2a91aa0af0af | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Pharmacy Value Alliance LLC | 8a6d6729-f6eb-4f68-e053-2a95a90a5c9e | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Rite Aid Corporation | 5da2ea79-f37a-b82b-e053-2a91aa0af0af | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | a381838b-d1ae-11c5-e053-2a95a90a7bcb | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Amerisource Bergen/Good Neighbor Pharmacy | 90a4d385-d548-420b-91d2-54d5e819fcce | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Cardinal Health | c2b33e78-6ab7-1785-e053-2995a90a9c4f | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | CVS Pharmacy | 3a59c4a9-5f86-406a-e054-00144ff8d46c | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Cardinal Health | 7e7e9366-af1e-e0ff-e053-2a91aa0a9487 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Cardinal Health | c2b02afc-5a8a-2a25-e053-2a95a90ae45c | 2025-10-24 | 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 |