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 39 of 63 · 1,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
application number: M007
rxcui: 1245468
unii: F05Q2T2JA0
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
AN12 Secret Therapy Feminine CleanserGLYCERINBESTVALUE Co., Ltdd2117c4c-9f1a-3a6e-e053-2995a90a0cc82025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 Skin Therapy Vita-B Aloe Soothing GelGLYCERINBESTVALUE Co., Ltdd274c973-057d-1c9f-e053-2995a90a82b12025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 ANUS PREMIUM CLEANSERGLYCERIN, ALLANTOINBESTVALUE Co., Ltdd11b7443-2dfc-3e17-e053-2a95a90afb762025-01-31WarningsExact identifier
unii: PDC6A3C0OX
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact identifier
application number: M007
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
unii: PDC6A3C0OX
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007

Reported adverse events (FAERS/openFDA)#

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