Stool Softener
- Product NDC
- 68016-587
- 11-digit product format
- 680160587
- Labeler code
- 68016
- Product ID
- 68016-587_48566dca-b40b-4a95-9c50-a0f037a64284
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-30
- Marketing end
- 2026-12-31
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- 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
- Brand name suffix
- Extra Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1245468 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 550000ba-0d6d-4666-8461-f591c14478b1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-587-00 | Stool SoftenerExtra Strength | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | 5 |
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 |
|---|---|---|---|---|---|---|
| Fleet | BISACODYL | C.B. Fleet Company, Inc. | 324e61eb-8f6b-48d7-85c2-b1b5642691c9 | 2025-06-23 | Warnings | M007 |
| Saline Laxative | SODIUM PHOSPHATE | Walgreen Company | fb260df0-7bda-4299-84a5-44c8f9447798 | 2025-06-18 | Warnings | M007 |
| De La Cruz Castor Oil | CASTOR OIL | DLC Laboratories, Inc. | 22fbad2e-e9fa-46ba-8617-ad79483cbe9a | 2025-06-13 | Warnings | M007 |
| Prolaxa | DOCUSATE SODIUM 250MG | Terrain Pharmaceuticals | 32610e42-f352-09fd-e063-6394a90abff6 | 2025-06-12 | Warnings | M007 |
| DOCUZEN | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Village Pharma | 29102014-9b0e-4899-958d-83111f94a612 | 2025-06-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 364b558b-69b5-bfa4-e063-6294a90acd0c | 2025-05-29 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 364bc4f5-6337-6c89-e063-6394a90a12ab | 2025-05-29 | Warnings | M007 |
| SENNA | SENNOSIDES | AARNA USA INC. | 364d4dfc-a089-1a27-e063-6394a90ad77b | 2025-05-29 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | Power Health, Products, Inc. | 3634b4e4-4fea-9428-e063-6394a90a6ad9 | 2025-05-28 | Warnings | M007 |
| MILK OF MAGNESIA ORIGINAL | MAGNESIUM HYDROXIDE | ATLANTIC BIOLOGICALS CORP. | 30fb7b5e-56a3-423e-ae57-432006b54fff | 2025-05-23 | Warnings | M007 |
| Senna Liquid | SENNA LIQUID | Belleview Biosciences | 35d5f217-b101-3cd8-e063-6394a90adccd | 2025-05-23 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 816c82f8-0fa5-4b22-a226-e8f22f3eaa1d | 2025-05-23 | Warnings | M007 |
| Senna Laxative | SENNA | PD-Rx Pharmaceuticals, Inc. | 2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa | 2025-05-21 | Warnings | M007 |
| Senna | SENNOSIDES | Akron Pharma Inc. | 55ce3969-d7a6-49c4-8c13-d95690efc1a6 | 2025-05-16 | Warnings | M007 |
| Saline Enema | SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC | Dynarex Corporation | 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 | 2025-05-14 | Warnings | M007 |
| Bisacodyl | BISACODYL | Rising Pharma Holdings, Inc. | 03429da4-1ce9-4789-bf54-ce1b3215b013 | 2025-05-13 | Warnings | M007 |
| COLACE EXTRA STRENGTH STOOL SOFTNER | DOCUSATE SODIUM | Atlantis Consumer Healthcare Inc. | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 2025-05-01 | Warnings | M007 |
| Senna | SENNOSIDES | PAI Holdings, LLC dba PAI Pharma | 7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed | 2025-04-28 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Belleview Bio Science | 335f41d7-5c22-7c17-e063-6294a90a8f28 | 2025-04-22 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | American Health Packaging | e5028f6d-d33d-47a9-8453-00af5cdf59a6 | 2025-04-20 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | 550000ba-0d6d-4666-8461-f591c14478b1 | 5 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | 550000ba-0d6d-4666-8461-f591c14478b1 | 5 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | 550000ba-0d6d-4666-8461-f591c14478b1 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68016-587-00 | 68016058700 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68016-587-00) | 2021-04-30 | 2026-12-31 | No | No | Current |