FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Prolaxa - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-08-05HUMAN OTC DRUG LABEL
Prolaxa - Terrain PharmaceuticalsTerrain Pharmaceuticals2025-06-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53225-2001-1Prolaxa100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53225-2001PROLAXA (DOCUSATE SODIUM 250MG) CAPSULE, LIQUID FILLED [TERRAIN PHARMACEUTICALS]1Current NDC, 1 package rows20250416_32610e42-f352-09fd-e063-6394a90abff6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-2001-1EA - Each53225-2001aa1310eb-6faa-4bfc-a75f-85befacab3b412025-06-13

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.

Matched openFDA labels page 49 of 63 · 1,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna S OrangeDOCUSATE SODIUM SENNOSIDESCare One (Retail Business Services, LLC.)3da76cb2-08c3-475d-9320-69450bbcf8cd2024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM, SENNOSIDESAmerisourceBergen (Good Neighbor Pharmacy) 4612268bf0d90-db4b-48f0-bce1-80127922bc822024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESUnited Natural Foods, Inc. dba UNFI3f519d42-72bc-4cc3-a43f-14b94a10eb9a2024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener plus LaxativeDOCUSATE SODIUM, SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)ebb35e67-4e83-445e-af6e-ecb43b1d3df62024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESTOP CARE (Topco Associates LLC)3984f4aa-2794-410c-ae9e-ee5bc31c04702024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
unii: PDC6A3C0OX
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESWinCo Foods, LLC2776d463-753d-4fee-ab5e-210ce36044112024-08-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with laxativeDOCUSATE SODIUM AND SENNOSIDESWinCo Foods, LLC3803830c-187d-4403-9606-db036418386f2024-08-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Magnesium CitrateHARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMONHarris Teeter, LLC1e8e01fc-2c89-9722-e063-6394a90a6acf2024-07-31WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESBest Choice (Valu Merchandisers Company)d5f90aa1-78e5-491f-b09d-399d54f3def12024-07-31WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)d4128fbd-32ba-4d2e-ae1a-cbe438f5b39b2024-07-31WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Senna laxativeSENNOSIDESWalgreensbfa089a6-4767-45e0-b663-ee7e8949d9a42024-07-25WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESGOOD SENSE17cdef7b-71bf-b4a6-e063-6294a90a5b742024-07-22WarningsExact identifier
unii: F05Q2T2JA0
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
application number: M007
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreensb6f0770e-671d-4965-9275-b1c224d7f06a2024-07-10WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services LLCb23e53d4-fd7d-452d-a851-35a143b6dcb42024-07-08WarningsExact identifier
unii: F05Q2T2JA0
Zenibell Snail IntensiveCreamGLYCERINMISOCOS97c19dca-237c-c968-e053-2a95a90aeae72024-07-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.