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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health, 110 dba Leader | d27dc1cc-5e17-40d3-84fe-c1792552cfd5 | 2026-08-25 | Warnings, Adverse reactions | M007 |
| HyVee Senna S | DOCUSATE SODIUM, SENNOSIDES | HyVee Inc | 4982b9c6-ed0e-24da-e063-6394a90a147f | 2026-08-24 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ccec364a-3135-4a5d-b4b0-86b832387b4e | 2026-08-24 | Warnings | M007 |
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | a1591da0-a1a9-9583-3cf5-788b8fee3814 | 2026-08-24 | M007 | |
| MiraFAST soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 2cee67dd-b71f-32b8-e063-6394a90ae864 | 2026-08-21 | Warnings | M007 |
| HyVee Senna S | DOCUSATE SODIUM, SENNOSIDES | HyVee Inc | 49837b2c-492f-2fed-e063-6294a90aaa24 | 2026-08-21 | Warnings | M007 |
| Senokot-S | STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | c24cdc5e-62e0-41a6-8afb-512202a569f4 | 2026-08-21 | Warnings | M007 |
| Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool Softener | DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG | Strategic Sourcing Services LLC | 5966ff80-7be2-788a-e063-6294a90ab4f3 | 2026-08-19 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | d22fb02f-09c4-476a-b6d6-d3a2fd30049d | 2026-08-18 | Warnings | M007 |
| Fibercon | CALCIUM POLYCARBOPHIL | Medtech Products Inc. | 59534afd-fe38-818a-e063-6394a90a21ea | 2026-08-18 | Warnings | M007 |
| CVS Stool Softener Fruit Punch | DOCUSATE SODIUM | CVS PHARMACY, INC | 0e6900d6-7dc9-47d6-a006-1695feb8d5a5 | 2026-08-17 | Warnings | M007 |
| CVS Senna Laxative | SENNOSIDES | CVS PHARMACY | 5a5565b2-827f-4fcc-a835-d827f62da8f9 | 2026-08-17 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 306fd12b-ed60-40dc-a5be-2dc394bd29d2 | 2026-08-17 | Warnings | M007 |
| CVS Health Childrens Saline Laxative | MAGNESIUM HYDROXIDE | CVS PHARMACY,INC. | e57e5529-2190-4c66-8397-bc2848739e59 | 2026-08-14 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | Morepen Bio Inc | 562d1b9a-09d8-92fc-e063-6394a90a1993 | 2026-08-14 | Warnings | M007 |
| CVS Health | NATURAL FIBER SUPPLEMENT | CVS Pharmacy,Inc. | 04dbe9aa-ed18-4d76-a840-d010445a8643 | 2026-08-14 | Warnings | M007 |
| CVS Fiber Therapy | METHYLCELLULOSE | CVS PHARMACY | e066f5bd-5f34-4e04-beec-3c7d6db49381 | 2026-08-13 | Warnings | M007 |
| Mineral oil | MINERAL OIL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 92f2147d-b52d-4282-b217-28f6095dca0e | 2026-08-12 | Warnings | M007 |
| CAREONE Orange Flavored | PSYLLIUM HUSK | FOODHOLD USA | 4b1cccd2-e941-4d51-9924-4ca35e3a4429 | 2026-08-11 | Warnings | M007 |
| CAREONE | PSYLLIUM HUSK | FOODHOLD USA | 3ec3ead0-382e-4765-bbe8-b21e7c7b42a6 | 2026-08-11 | 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 |