FDA.reportPublic FDA data

Prolaxa

Product NDC
53225-2001
11-digit product format
532252001
Labeler code
53225
Product ID
53225-2001_37683907-1819-da31-e063-6394a90acc44
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 250mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Terrain Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-15
Substance
DOCUSATE SODIUM
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Prolaxa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245468Internal RxNorm lookup
2711894Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32610e42-f352-09fd-e063-6394a90abff6Available on FDA.report

DailyMed Package Descriptions#

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

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

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

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 5 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENNA TIMESENNOSIDESBryant Ranch Prepackbdcf37fc-3938-4d3f-b669-35c6939eac4f2026-07-10WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEPreferred Pharmaceuticals Inc.f8bba8cb-a111-4285-8bdb-2273a049c3bb2026-07-08WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
application number: M007
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
application number: M007
SennaSENNOSIDES 8.6 MG TABLETSAarkish Pharmaceuticals NJ Inc.564bc9a5-13b5-4cce-a349-6b2e122683ed2026-07-01WarningsExact identifier
application number: M007
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
application number: M007
ENEMEEZDOCUSATE SODIUMQuest Products, LLC0b06445d-0839-497e-bdff-e0fe224a77382026-06-30WarningsExact identifier
application number: M007
ENEMEEZ PlusDOCUSATE SODIUM AND BENZOCAINEQuest Products, LLC1670ca59-7275-4ac6-bef4-674a7b24c7b32026-06-30WarningsExact identifier
application number: M007
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens20c43036-830b-0e1d-e063-6394a90adf5f2026-06-25WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packagingbe7cab51-ce7e-465d-95db-083e69288cfd2026-06-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEVi-Jon, LLCba490c22-19f0-4887-9509-bd3d32e0f5b12026-06-24Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEKROGER COMPANYa1b0c638-6c34-1b72-e053-2995a90acc852026-06-24WarningsExact identifier
application number: M007
Womens LaxativeWOMENS LAXTIVEAllegiant Health549a11d1-a096-4c22-96b4-2d4f54f460222026-06-24WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf4259fda-19d4-087e-e053-2995a90a70812026-06-22WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMGeri-Care Pharmaceuticals, Corp3ec42148-6786-22f2-e054-00144ff8d46c2026-06-18WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN32610e42-f352-09fd-e063-6394a90abff62
2711894Prolaxa 250 MG Oral CapsulePSN32610e42-f352-09fd-e063-6394a90abff62
2711894docusate sodium 250 MG Oral Capsule [Prolaxa]SBD32610e42-f352-09fd-e063-6394a90abff62
1245468docusate sodium 250 MG Oral CapsuleSCD32610e42-f352-09fd-e063-6394a90abff62
1245468DOSS Sodium 250 MG Oral CapsuleSY32610e42-f352-09fd-e063-6394a90abff62
2711894DOSS sodium 250 MG Oral Capsule [Prolaxa]SY32610e42-f352-09fd-e063-6394a90abff62
2711894Prolaxa 250 MG Oral CapsuleSY32610e42-f352-09fd-e063-6394a90abff62
1245468docusate sodium 250 MG Oral CapsulePSN3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
2711894Prolaxa 250 MG Oral CapsulePSN3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
2711894docusate sodium 250 MG Oral Capsule [Prolaxa]SBD3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
1245468docusate sodium 250 MG Oral CapsuleSCD3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
1245468DOSS Sodium 250 MG Oral CapsuleSY3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
2711894DOSS sodium 250 MG Oral Capsule [Prolaxa]SY3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1
2711894Prolaxa 250 MG Oral CapsuleSY3ba0c0d9-9e6f-a2e6-e063-6394a90a202d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53225-2001-153225200101100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (53225-2001-1) 2025-04-15NoNoCurrent