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 |
|---|---|---|---|---|---|---|
| CVS Gentle Laxative | BISACODYL | CVS Pharmacy | 0cca1516-fc8d-4471-bd37-a6230fd225e2 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Gentle Laxative | BISACODYL | RITE AID PHARMACY | 0fb853db-8d97-64d6-e063-6294a90abeb5 | 2026-01-14 | Warnings | M007 |
| Rite-Aid Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fb8f488-3386-29b9-e063-6294a90a014c | 2026-01-14 | Warnings | M007 |
| Rite-Aid Childrens Glycerin Laxative | GLYCERIN SUPPOSITORY | RITE AID CORPORATION | 0fbe4dfd-1d5d-fc31-e063-6394a90ab317 | 2026-01-14 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 92659389-c36f-499b-b284-5b520e50e9a6 | 2026-01-14 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | AVPAK | af75d33f-b081-4b9d-bc12-d2829fa1f0cf | 2026-01-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Care One (Retail Business Services, LLC.) | 597d2e9c-1adb-4c7d-ada3-de5c2db69c74 | 2026-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Mineral oil Laxative | MINERAL OIL | Strategic Sourcing Services LLC | ea6da66c-6825-4cd7-8791-45b537bf203a | 2026-01-08 | Warnings | M007 |
| Sunmark Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 06720229-7d58-499e-b7de-cb4bda5ae416 | 2026-01-08 | Warnings | M007 |
| HealthMart Mineral Oil Single Laxative | MINERAL OIL | Strategic Sourcing Services LLC | 1238ec69-1ea3-4773-9f13-71f0ae0a3553 | 2026-01-08 | Warnings | M007 |
| HealthMart Saline Single Laxative | SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Strategic Sourcing Services LLC | 689228de-1f3e-4205-853d-6004d6248857 | 2026-01-08 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | CVS Pharmacy | c445864f-fc88-4885-9f40-d189b9dc4290 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | c46a1f7c-12e3-4be1-b9e4-d3edac0f4386 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TOP CARE (Topco Associates LLC) | 44fe6ce0-5fed-418f-8a6a-d6132e288328 | 2026-01-07 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Strategic Sourcing Services LLC | 24e29f00-f1cf-4e92-bd67-3f6f820af783 | 2026-01-07 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 33000a06-e030-433a-8f9c-7ae5c08037fa | 2026-01-06 | Warnings | M007 |
| Stool Softener Regular Strength | DOCUSATE SODIUM | Sam's West, Inc | 1eca5910-b0bf-4e07-8211-36dba52b3de7 | 2026-01-06 | Warnings | M007 |
| Milk of Magnesia | MAGNESIUM HYDROXIDE | Major Pharmaceuticals | c3d14605-fdec-49fc-b0ee-d4c3ae5f42b5 | 2026-01-05 | Warnings | M007 |
| GeriCare Sorbitol Solution | SORBITOL | GERI-CARE PHARMACEUTICALS, CORP | b4dd7a41-380e-d94b-e053-2a95a90ac34a | 2025-12-31 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c | 2025-12-31 | 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 |