STOOL SOFTENER
- Product NDC
- 57896-421
- 11-digit product format
- 578960421
- Labeler code
- 57896
- Product ID
- 57896-421_548956c0-c6c7-be65-e063-6294a90a44fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- docusate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceuticals, Corp
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-09-01
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- 2027-12-31
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 |
|---|---|
| 1099279 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ec42148-6786-22f2-e054-00144ff8d46c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-421-01 | STOOL SOFTENER | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 57896-421-10 | STOOL SOFTENER | 1000 in 1 BOTTLE | TABLET | 1000 | 5 | |
| 57896-421-20 | STOOL SOFTENER | 200 in 1 BOTTLE | TABLET | 200 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-421-01 | EA - Each | 57896-421 | 81c968a7-8921-4237-8518-0aea0336f8ed | 1 | 2016-11-08 |
| 57896-421-10 | EA - Each | 57896-421 | 3f2e704c-f32c-409c-b2b9-3587365c5f1d | 1 | 2016-11-08 |
| 57896-421-20 | EA - Each | 57896-421 | f0110dec-7b8d-45b9-a166-56a71b6ddde2 | 1 | 2022-03-09 |
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 |
|---|---|---|---|---|---|---|
| Magnesium Citrate | MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Major Pharmaceuticals | 088e5543-c947-af78-e063-6294a90a8bc4 | 2023-10-25 | Warnings | M007 |
| DOK | DOCUSATE SODIUM | MAJOR PHARMACEUTICALS | 7a92070d-98cc-662f-e053-2991aa0aa1b2 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | KROGER COMPANY | a1afaa71-7e8c-5a49-e053-2a95a90a4db0 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Asclemed USA, Inc. | 30fc8c07-c26b-4bcc-a727-6e193f5727fd | 2023-10-16 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | MEIJER, INC. | e43bd2ed-17c7-4530-af72-81a7ad70069c | 2023-10-12 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Care One (Retail Business Services, LLC.) | 9adaec97-43e3-48f2-96c8-c508b693676c | 2023-10-05 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | TopCo Associates, LLC | 83aeb90a-ab00-4e26-aa44-5259dce59018 | 2021-04-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 9fbe783e-ddd9-445a-852a-00f4ad754880 | 2021-04-20 | Warnings | M007 |
| Topcare Stool Softener | DOCUSATE SODIUM | TopCo Associates, LLC | 6f4fddda-4129-4087-b0e4-ababc5558484 | 2021-02-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Allegiant Health | 30c9ff75-cee4-4632-86fd-acfdf5ee85af | 2020-10-27 | Warnings | M007 |
| Stool Softener | MARC GLASSMAN | Marc Glassman, Inc. | 909cd222-d836-416f-aa7d-deb4a0c5a560 | 2020-09-08 | Warnings | M007 |
| Senna Lax | SENNOSIDES 8.6MG | Allegiant Health | 94a9c24a-07c3-4535-b810-b7abc9fc5ad5 | 2019-12-11 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Marc Glassman, Inc. | ec34fc1e-d122-4fa4-859e-e89e3e12edd5 | 2019-09-18 | Warnings | M007 |
| Womens Laxative | BISACODYL | Marc Glassman, Inc. | aeb3c49b-cbf5-4a47-b19c-e77fbb987a49 | 2019-09-17 | Warnings | M007 |
| Bisacodyl 5mg | BISACODYL 5MG | Allegiant Health | 46a377f5-822b-496f-a73b-66d8f902680a | 2019-03-26 | Warnings | M007 |
| Laxative Enteric Coated | BISACODYL 5MG | Allegiant Health | 51f1c6c0-770c-4426-820b-bc1f42e143fd | 2019-02-07 | Warnings | M007 |
| Senna-Lax | SENNOSIDES | Marc Glassman, Inc. | 7dd97c54-2ba1-4629-87b9-1ba0913fe531 | 2016-12-27 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1099279 | docusate sodium 100 MG Oral Tablet | PSN | 3ec42148-6786-22f2-e054-00144ff8d46c | 5 |
| 1099279 | docusate sodium 100 MG Oral Tablet | SCD | 3ec42148-6786-22f2-e054-00144ff8d46c | 5 |
| 1099279 | DOSS Sodium 100 MG Oral Tablet | SY | 3ec42148-6786-22f2-e054-00144ff8d46c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57896-421-01 | 57896042101 | 100 TABLET in 1 BOTTLE (57896-421-01) | 100 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 57896-421-10 | 57896042110 | 1000 TABLET in 1 BOTTLE (57896-421-10) | 1000 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 57896-421-20 | 57896042120 | 200 TABLET in 1 BOTTLE (57896-421-20) | 200 tablet | 2019-05-01 | 0000-00-00 | No | No | Current |