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 |
|---|---|---|---|---|---|---|
| Laxative Docusate Sodium with Senna | DOCUSATE SODIUM AND SENNOSIDES | TOPCO ASSOCIATES LLC | cf9075d8-e20e-419a-b996-9b12f49f05f2 | 2025-01-01 | Warnings | M007 |
| Vegetable Laxative and Stool Softner | DOCUSATE SODIUM AND SENNOSIDES | TOPCO ASSOCIATES LLC | e84d693d-0041-4c11-8f6a-b5c332f79af9 | 2025-01-01 | Warnings | M007 |
| Acetaminophen | EXTRA STRENGTH PAIN RELIEF | NuCare Pharmaceuticals,Inc. | a32f346e-71d0-cc11-e053-2a95a90ae88c | 2024-12-31 | Warnings | M007 |
| Laxacin | DOCUSATE SODIUM AND SENNOSIDES | Advanced Rx Pharmacy of Tennessee, LLC | fe7d4d75-0f8a-1e7d-e053-6394a90afb4d | 2024-12-31 | Warnings | M007 |
| NATUREPLEX Enema | (SALINE) | Natureplex, LLC | 0bd6d0a8-33e5-40be-a6c6-33fea92b11dd | 2024-12-31 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON | CVS Pharmacy, Inc. | fb7f9b67-ff0e-3af4-e053-6294a90ac539 | 2024-12-30 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | CVS Pharmacy, Inc. | fb808dc5-bf80-836c-e053-6294a90a80aa | 2024-12-30 | Warnings | M007 |
| Magnesium Citrate | CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | CVS Pharmacy, Inc. | fb80ffce-a7b6-7f19-e053-6294a90a5c6b | 2024-12-30 | Warnings | M007 |
| Foster and Thrive Castor Oil | CASTOR OIL | Strategic Sourcing Services, LLC | 004d1dc2-47c1-84d1-e063-6394a90a2471 | 2024-12-30 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | A-S Medication Solutions | 946abcdb-96bd-43e6-992a-bb97679c00f0 | 2024-12-30 | Warnings | M007 |
| HEB Maximum strength Laxative pills | SENNOSIDES | H E B | 86e5dff5-91e6-47a5-8f3c-b1e86adfc1f4 | 2024-12-26 | Warnings | M007 |
| Equaline Regular Strength Chocolated Stimulant Laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | e9200d63-a0d1-4f68-bb5e-7507c46cf800 | 2024-12-26 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effad954-b70d-d8e6-e053-2a95a90acaf7 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effad365-d76e-71af-e053-2995a90aa020 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | WALGREEN COMPANY | effaeff6-c48b-1558-e053-2995a90ab52f | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | STRATEGIC SOURCING SERVICES | f9e1291a-f64d-2431-e053-6394a90a35f1 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | AMERISOURCE BERGEN | f384094e-c4d2-3882-e053-2995a90a7794 | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | AMERISOURCE BERGEN | f3847b0f-802d-73d7-e053-2a95a90a5bbe | 2024-12-23 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | STRATEGIC SOURCING SERVICES | f9e1291a-f650-2431-e053-6394a90a35f1 | 2024-12-23 | Warnings | M007 |
| Leader Regular Strength Chocolate Laxative sennosides | SENNOSIDES | CARDINAL HEALTH | 1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e | 2024-12-23 | 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 |