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 |
|---|---|---|---|---|---|---|
| Milk of Magnesia mint | MAGNESIUM HYDROXIDE | Meijer, Inc. | bb8ba371-f53c-1088-e053-2a95a90a4cbf | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | STRATEGIC SOURCING SERVICES LLC | 00c61622-367b-0a5b-e063-6294a90a6706 | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Strategic Sourcing Services LLC | 003a3c0d-7a48-e44d-e063-6394a90a3f4a | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Geri-Care Pharmaceuticals, Corp | 2d1be236-e136-4727-a52d-714f62880088 | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d690d82-e4fb-57ad-e053-2a91aa0a38ea | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d6a8048-93e7-42e5-e053-2991aa0acabd | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | AMERISOURCEBERGEN DRUG CORPORATION | 5d7f5a38-4222-5bfb-e053-2991aa0a17e3 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | CARDINAL HEALTH | af4b6b64-97c9-a794-e053-2a95a90aaf0b | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | CARDINAL HEALTH | af5ddf5d-b1f5-2918-e053-2995a90a2d61 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | H E B | ab998776-6b30-9f17-e053-2995a90a96cd | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | H E B | abfe89c8-86f1-bd1e-e053-2995a90af773 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | GOODSENSE | a951617d-c6fa-75e0-e053-2995a90afcf8 | 2023-11-07 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | KROGER COMPANY | a1b04366-ff67-3bb3-e053-2a95a90a816c | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | BETTER LIVING BRANDS, LLC | b9440381-df40-4bc7-e053-2995a90ae83f | 2023-11-07 | Warnings | M007 |
| Milk of Magnesia mint | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83f6027-51a0-1730-e053-2995a90a553b | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83eb807-d522-4408-e053-2a95a90a7926 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | TOP CARE (TOPCO ASSOCIATES LLC) | b83f0c1c-0e90-2888-e053-2995a90a0b96 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | DOLGENCORP, INC. | b6991abf-9819-701c-e053-2a95a90ac0b4 | 2023-11-07 | Warnings | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 7722145c-913c-4ed5-a9b2-a6c343064066 | 2023-11-06 | Warnings | M007 |
| MILK OF MAGNESIA CHERRY | MAGNESIUM HYDROXIDE | Chain Drug Marketing Association | 12361478-d178-4950-9458-4e2e56565599 | 2023-11-06 | 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 |