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.
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| DOK | DOCUSATE SODIUM | MAJOR PHARMACEUTICALS | 7a92070d-98cc-662f-e053-2991aa0aa1b2 | 2023-10-23 | Warnings | M007 F05Q2T2JA0 |
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| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | M007 F05Q2T2JA0 |
| Docusate Sodium | DOCUSATE SODIUM | Asclemed USA, Inc. | 30fc8c07-c26b-4bcc-a727-6e193f5727fd | 2023-10-16 | Warnings | M007 F05Q2T2JA0 |
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| Stool Softener Extra Strength | DOCUSATE SODIUM | MEIJER, INC. | e43bd2ed-17c7-4530-af72-81a7ad70069c | 2023-10-12 | Warnings | M007 1245468 F05Q2T2JA0 |
| Hemorrhoidal Pain Relief with Aloe and VitaminE | HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE | NeilMed pharmaceuticals Inc. | 076b5021-8ba0-0204-e063-6294a90a3337 | 2023-10-11 | Warnings | PDC6A3C0OX |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Care One (Retail Business Services, LLC.) | 9adaec97-43e3-48f2-96c8-c508b693676c | 2023-10-05 | Warnings | M007 F05Q2T2JA0 |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 6DC9Q167V3 PDC6A3C0OX |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 6DC9Q167V3 PDC6A3C0OX |
| AnubisMed | AZELAIC ACID, SALICYLIC ACID | ANUBIS COSMETICS SL | ebf3153d-30f5-54e4-e053-2995a90a74b1 | 2023-09-05 | Warnings | 6DC9Q167V3 |
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| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | PDC6A3C0OX |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | PDC6A3C0OX |
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | PDC6A3C0OX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.