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 8 of 63 · 1,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
Magnesium CitrateMAGNESIUM CITRATEGeri-Care Pharmaceuticals, Corp99eb67ca-301c-dfdb-e053-2a95a90aff6f2026-05-28WarningsExact identifier
application number: M007
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Epsom SaltMAGNESIUM SULFATECVS PHARMACY, INC1f9e72dc-a394-420d-8fe8-fc4d0f6906ed2026-05-27WarningsExact identifier
application number: M007
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
application number: M007
unii: PDC6A3C0OX
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy9983095a-6ef4-4ad7-acc5-e34221fb7c632026-05-20WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCVS PHARMACY, INC056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1382026-05-20WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Senna SyrupSENNOSIDES 8.8MG/5MLAldama Pharmaceuticals, Inc491255c6-465f-a78a-e063-6394a90aa4082026-05-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMCardinal Health 107, LLC40385b89-a855-4ca2-992a-df5eb677be152026-05-15WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticalscc8d1556-f108-4166-837c-48f81152877e2026-05-12WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGOODSENSEa9509715-cc4f-595d-e053-2a95a90ae31f2026-05-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMForreal Pharmaceuticals, LLC118dccb7-5df2-432d-b7d3-37b3f1ade0aa2026-05-07WarningsExact identifier
unii: F05Q2T2JA0
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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