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 48 of 63 · 1,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
unii: PDC6A3C0OX
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
application number: M007
rxcui: 1245468
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B4fcfb8ff-5b99-4bb3-9a2b-c95f47d74b8b2024-09-09WarningsExact identifier
unii: F05Q2T2JA0
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESAmerisourceBergen (Good Neighbor Pharmacy) 461227e573645-b156-4768-8e69-00998f5080732024-09-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)7f4f7fcb-5202-4184-80ef-b4b6c6460c2f2024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5bdc4291-2565-49be-93f1-84f60f9831352024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4bcf2ea2-7de2-4b89-b7b4-e132457f8a812024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)19e10544-81f4-4c2d-8a63-238c562c2f5c2024-09-04WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFIdb15be6e-9ac6-4cf9-89f8-14480c89fcd22024-09-04WarningsExact identifier
unii: F05Q2T2JA0
SennaSENNOSIDESProficient Rx LP5f7f0df4-dabe-4c8f-a2b5-766f20af2f462024-09-01WarningsExact identifier
application number: M007
Fiber caplets 147CALCIUM POLYCARBOPHILChain Drug Marketing Association Inc.17e2a50d-1867-49fe-e063-6394a90a56df2024-08-27WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVE PILLSSENNOSIDESTARGET CORPORATION7cae52ae-931c-3e7c-e053-2991aa0a83962024-08-22WarningsExact identifier
application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
SENNA LAXATIVESENNOSIDES 8.6 MGTARGET CORPORATION7cab058f-3647-7124-e053-2a91aa0a41bd2024-08-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Sool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)7104b955-fadd-4ce7-9342-fb28027fc4a92024-08-12WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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