NDC 53225-2001-01 - Prolaxa
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 53225-2001
- Requested NDC
- 53225-2001-01
- Package NDCs from labels
- 53225-2001-1, 53225-2001-01
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2025-08-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Prolaxa - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2025-08-05 | HUMAN OTC DRUG LABEL |
| Prolaxa - Terrain Pharmaceuticals | Terrain Pharmaceuticals | 2025-06-12 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53225-2001-1 | Prolaxa | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53225-2001 | PROLAXA (DOCUSATE SODIUM 250MG) CAPSULE, LIQUID FILLED [TERRAIN PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250416_32610e42-f352-09fd-e063-6394a90abff6.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53225-2001-1 | EA - Each | 53225-2001 | aa1310eb-6faa-4bfc-a75f-85befacab3b4 | 1 | 2025-06-13 |
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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | c1e9863a-c229-4694-b450-6b0e0ad37503 | 2024-04-30 | Warnings | M007 1245468 F05Q2T2JA0 |
| Stool Softener Laxative | DOCUSATE SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 96c7f8bc-be95-40d1-9977-44b7cc6582df | 2024-04-22 | Warnings | M007 F05Q2T2JA0 |
| Pedia-Lax | MAGNESIUM HYDROXIDE | C.B. Fleet Company, Inc. | 975f24d8-218c-40f4-84a5-558acf34329d | 2024-04-11 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | H E B | 2f9e2723-53a7-47a8-8c41-87bffc4e50dd | 2024-04-09 | Warnings | M007 F05Q2T2JA0 |
| Senna | SENNOSIDES | H E B | d047e4e9-b8ac-498e-9fde-8af5d415edaa | 2024-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 5b8bcc6c-de03-4d73-a76f-6f4c371cf250 | 2024-04-09 | Warnings | M007 F05Q2T2JA0 |
| Stool Softener | DOCUSATE SODIUM | H E B | 1dd2be7e-bdca-4e43-b853-3ed10b636632 | 2024-04-08 | Warnings | M007 1245468 F05Q2T2JA0 |
| PREPARATION H Maximum Strength | GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL | Haleon US Holdings LLC | 7cc03d2e-e708-589a-d9bb-58ebbda989c0 | 2024-04-05 | Warnings | PDC6A3C0OX |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 1f11cf85-b094-4ca4-8b48-2d3a9093304b | 2024-04-04 | Warnings | M007 1245468 F05Q2T2JA0 |
| SENNA-PLUS | SENNOSIDES AND DOCUSATE SODIUM | Bryant Ranch Prepack | 7f8396e7-07f0-4c9c-be8a-9dc00139cb83 | 2024-04-04 | Warnings | F05Q2T2JA0 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 89106733-69f1-469b-9d07-f06ac09b2fb6 | 2024-04-02 | Warnings | M007 F05Q2T2JA0 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | e0b7acab-add4-4daf-b1df-bb7cf5ca8e19 | 2024-04-01 | Warnings | M007 |
| Envirotox | TRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM. | BioActive Nutritional, Inc. | 2b5cfdba-cf4d-4eb0-8c60-20eac6922663 | 2024-03-26 | Warnings | 6DC9Q167V3 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 89dc2063-6744-4412-89be-90990090b57c | 2024-03-19 | Warnings | M007 F05Q2T2JA0 |
| Senna Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2322765d-6f08-48d4-a500-818a8a558f6f | 2024-03-19 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | dcab26ff-2c10-4478-90a8-c89d87261bfa | 2024-03-19 | Warnings | M007 F05Q2T2JA0 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4d1391da-7874-4a51-a468-2843ecf6f92b | 2024-03-18 | Warnings | M007 F05Q2T2JA0 |
| Stool Softener Laxative | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | adaea845-e029-422d-a947-d8ce8f5787ed | 2024-03-18 | Warnings | M007 F05Q2T2JA0 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8b033d56-b95b-4905-9f33-cf2fbd61ce35 | 2024-03-15 | Warnings | M007 F05Q2T2JA0 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | CVS Pharmacy | 6a97a181-1ec2-473d-a588-db2f2f2f662d | 2024-03-14 | Warnings | M007 F05Q2T2JA0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.