Prolaxa
- Product NDC
- 80425-0540
- 11-digit product format
- 804250540
- Labeler code
- 80425
- Product ID
- 80425-0540_3ba0c7e2-c13b-a7d7-e063-6394a90abf07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium 250mg
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-05
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Prolaxa
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0540-1 | Prolaxa | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0540-1 | EA - Each | 80425-0540 | 19973467-6708-4b6b-83a2-3a5b20f2a0fb | 1 | 2025-09-12 |
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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | b1d903a5-1d5f-44d4-9939-a4b86e5a620d | 2024-05-23 | Warnings | M007 |
| Senna laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | 30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8 | 2024-05-23 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | MEIJER, INC. | 11fe5bd0-585a-ad8a-e063-6294a90a3ae8 | 2024-05-22 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Sam's West, Inc | b14d2495-1092-4063-869f-73a7e8c28708 | 2024-05-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d | 2024-05-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | c0898583-4bbb-41d5-9e84-00cca823024f | 2024-05-15 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9c986ca8-d540-49c1-b092-94c1bf837c07 | 2024-05-09 | Warnings | M007 |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 381f4179-0c3b-41f8-927c-c88534ebe06d | 2024-05-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | ed20d198-e935-200e-e053-2a95a90a309b | 2024-05-02 | Warnings | M007 |
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Major Pharmaceuticals | 1768b470-2808-fa46-e063-6394a90ac8d9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Stimulant laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9467e1f7-19bb-4fb3-853b-75c4d28bb9a9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | c1e9863a-c229-4694-b450-6b0e0ad37503 | 2024-04-30 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 96c7f8bc-be95-40d1-9977-44b7cc6582df | 2024-04-22 | Warnings | M007 |
| Pedia-Lax | MAGNESIUM HYDROXIDE | C.B. Fleet Company, Inc. | 975f24d8-218c-40f4-84a5-558acf34329d | 2024-04-11 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | H E B | 2f9e2723-53a7-47a8-8c41-87bffc4e50dd | 2024-04-09 | Warnings | M007 |
| Senna | SENNOSIDES | H E B | d047e4e9-b8ac-498e-9fde-8af5d415edaa | 2024-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 5b8bcc6c-de03-4d73-a76f-6f4c371cf250 | 2024-04-09 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | H E B | 1dd2be7e-bdca-4e43-b853-3ed10b636632 | 2024-04-08 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 1f11cf85-b094-4ca4-8b48-2d3a9093304b | 2024-04-04 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 2711894 | Prolaxa 250 MG Oral Capsule | PSN | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 2711894 | docusate sodium 250 MG Oral Capsule [Prolaxa] | SBD | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 2711894 | DOSS sodium 250 MG Oral Capsule [Prolaxa] | SY | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
| 2711894 | Prolaxa 250 MG Oral Capsule | SY | 3ba0c0d9-9e6f-a2e6-e063-6394a90a202d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 80425-0540-1 | 80425054001 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (80425-0540-1) | 2025-08-05 | No | No | Current |