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 |
|---|---|---|---|---|---|---|
| Bisacodyl | BISACODYL SUPPOSITORIES | Oncor Pharmaceuticals | 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c | 2025-01-24 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NuCare Pharmaceuticals, Inc. | 2c65319f-6cf5-aa90-e063-6394a90ad662 | 2025-01-23 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health (Leader) 70000 | cde87f95-73c0-46f5-9349-37e04096048c | 2025-01-22 | Warnings | M007 |
| Senna-Tabs | SENNA 8.6MG | Ulai Health LLC | 485129a0-8340-4f61-be51-5abff5032b8d | 2025-01-20 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Topco Associates, LLC | 0609468d-ee66-49af-be40-e51965b88f6f | 2025-01-20 | Warnings | M007 |
| Soluble Fiber | METHYLCELLULOSE | United Natural Foods, Inc. dba UNFI | 6decd5ef-e8e1-44ae-8465-6266cf18e81e | 2025-01-20 | Warnings | M007 |
| Perdiem | SENNOSIDES, STIMULANT LAXATIVE | Haleon US Holdings LLC | 6b256c8f-3953-4c69-9a16-ffa0511bdbcd | 2025-01-16 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | Everpharm LLC | 0ea9f2b5-4533-4b71-b019-10ecb3c06459 | 2025-01-16 | Warnings | M007 |
| Anecream 5 | LIDOCAINE 5% | Focus Health Group | 1810edc3-093e-402f-bcb0-9c731da283a7 | 2025-01-15 | Warnings | M007 |
| Senna | SENNOSIDES | Reliable 1 Laboratories LLC | ae46a611-20f2-74c8-e053-2995a90a32ce | 2025-01-15 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Reliable-1 Laboratories LLC | a97a1829-f62f-2014-e053-2a95a90a8cc5 | 2025-01-15 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 4d678da0-9ada-4d00-9db9-33b45c776107 | 2025-01-15 | Warnings | M007 |
| Goodsense Fiber laxative 147 | CALCIUM POLYCARBOPHIL | GoodSense | 17f5570b-be85-9dce-e063-6294a90abeaf | 2025-01-14 | Warnings | M007 |
| Sunmark Mineral Oil Laxative | MINERAL OIL | Strategic Sourcing Services | c54f7df2-3845-425f-b13e-3dc000123f3c | 2025-01-14 | Warnings | M007 |
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Ulai Health LLC | c0e27b02-8ef2-4239-8f8c-790f7d978dc0 | 2025-01-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Major Pharmaceuticals | 1541ff5b-11f8-444b-a2a0-8e3086ae650a | 2025-01-10 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | AvPAK | f31a4349-7826-45c0-9388-6b938d167b7a | 2025-01-09 | Warnings | M007 |
| Docusate sodium | DOCUSATE SODIUM | APNAR PHARMA LP | 05b0732b-012f-78ee-e063-6294a90a839a | 2025-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Saline Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | McKesson | e5fdfcfd-5340-4929-9f68-2696110cca8e | 2025-01-07 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. | ee06868b-f741-8da2-e053-2a95a90a9772 | 2025-01-02 | 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 |