DOCUSATE SODIUM, EXTRA STRENGTH
- Product NDC
- 80513-101
- 11-digit product format
- 805130101
- Labeler code
- 80513
- Product ID
- 80513-101_55fe1154-f793-7cb6-e063-6294a90aad06
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCUSATE SODIUM
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-25
- Marketing end
- 2028-12-31
- 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
- DOCUSATE SODIUM, EXTRA STRENGTH
- Brand name suffix
- 250 MG
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 |
|---|---|
| fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-101-01 | DOCUSATE SODIUM, EXTRA STRENGTH250 MG | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | 2 |
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 |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80513-101-01 | 80513010101 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-101-01) | 2023-05-25 | 2028-12-31 | No | No | Historical |