Docusate Sodium - Stool Softener Laxative
- Product NDC
- 0904-7183
- 11-digit product format
- 009047183
- Labeler code
- 0904
- Product ID
- 0904-7183_362b3bf1-c0d0-4dee-a2c9-093d772a8b56
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-04
- Marketing end
- 2027-08-31
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 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
- Docusate Sodium - Stool Softener Laxative
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 |
|---|---|
| cc8d1556-f108-4166-837c-48f81152877e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7183-61 | Docusate Sodium - Stool Softener Laxative | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 5 | |
| 0904-7183-61 | Docusate Sodium - Stool Softener Laxative | 10 in 1 CARTON | CAPSULE, LIQUID FILLED | 10 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7183-61 | EA - Each | 0904-7183 | da67df6d-a60f-4a39-8851-7609176262e6 | 1 | 2021-10-08 |
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 Syrup | NATURAL VEGETABLE LAXATIVE | Method Pharmaceuticals | ce83ba78-7e0d-b37f-e053-2995a90a9383 | 2025-10-21 | Warnings | M007 |
| Fiber Lax | CALCIUM POLYCARBOPHIL | PD-Rx Pharmaceuticals, Inc. | 730198a5-b6d9-4fc7-b053-a7c65a93c540 | 2025-10-20 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Consortium LLC | 4694f05b-d927-4e15-9630-a0a1cddb3cbb | 2025-10-16 | Warnings | M007 |
| Glycerin | GLYCERIN | Amerisource Bergen/Good Neighbor Pharmacy | e6a8914f-cfd9-4c72-abaa-22189bf0faef | 2025-10-16 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Marketing Association Inc. | 3386fada-6b7f-46fd-e063-6294a90abffc | 2025-10-16 | Warnings | M007 |
| Senna Syrup | SENNA SYRUP | Kesin Pharma Corporation | 360fb98d-c6ad-7bcc-e063-6294a90a9453 | 2025-10-14 | Warnings | M007 |
| Glycerin | GLYCERIN | H E B | 3d0566a1-57a5-6a31-e054-00144ff88e88 | 2025-10-09 | Warnings | M007 |
| SENNA WITH DOCUSATE SODIUM | DOCUSATE SODIUM AND SENNOSIDES | HHH Pharmaceuticals | 2bbb1b99-d43c-40a3-bc53-e18e8394c318 | 2025-10-08 | Warnings | M007 |
| Castor Oil | CASTOR OIL | BIONPHARMA INC. | 3f9728e8-c7a2-6cfb-e063-6394a90a8f1d | 2025-10-06 | Warnings | M007 |
| Sennosides | SENNOSIDES | InvaTech Pharma Solutions LLC | 3de39fbd-29be-fce7-e063-6394a90a67ae | 2025-10-03 | Warnings | M007 |
| Metamucil Therapy for regularity | PSYLLIUM HUSK | The Procter & Gamble Manufacturing Company | a9824f73-5ea2-4a65-a926-3a57561441b8 | 2025-10-01 | Warnings | M007 |
| OneLAX SENNA | SENNA | Atlantic Biologicals Corp. | 40202c76-4273-88fd-e063-6394a90a07b2 | 2025-10-01 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE ORAL SOLUTION | Bionpharma, Inc. | 4019fbd0-fcf9-77a6-e063-6294a90a5ae7 | 2025-09-30 | Warnings | M007 |
| LEADER HYDROCORTISONE WITH ALOE | HYDROCORTISONE | LEADER | 39916470-15bf-4bd0-96e2-b909d68cf9c4 | 2025-09-29 | Warnings | M007 |
| Leader Ready to Use Mineral Oil Laxative | MINERAL OIL | Cardinal Health | b8494d02-8a7d-47b4-80b0-b8ab51b625fd | 2025-09-29 | Warnings | M007 |
| Leader Ready to Use Saline Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Cardinal Health | 1b4f9c28-0547-4922-aa15-990c6fd9dc9f | 2025-09-29 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Kesin Pharma Corporation | 3f7cff50-749b-5275-e063-6394a90af407 | 2025-09-23 | Warnings | M007 |
| Stimulant Laxative Plus Stool Softener | DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG | Bryant Ranch Prepack | 12f613e4-c919-4cc4-a445-eb30039ae45f | 2025-09-18 | Warnings | M007 |
| Saline Laxative | SALINE LAXATIVE | Major Pharmaceuticals | b3758ffe-1bac-4df6-9714-5e33e9d28d90 | 2025-09-16 | Warnings | M007 |
| Gentle Laxative | BISACODYL | BETTER LIVING BRANDS LLC. | f29d57f6-0938-d459-e053-2995a90ad86b | 2025-09-13 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | cc8d1556-f108-4166-837c-48f81152877e | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | cc8d1556-f108-4166-837c-48f81152877e | 5 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 5 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | cc8d1556-f108-4166-837c-48f81152877e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-7183-61 | 00904718361 | 10 BLISTER PACK in 1 CARTON (0904-7183-61) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 10 blister pack | 2021-09-04 | 2027-08-31 | No | No | Current |