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 40 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milk of Magnesia mintMAGNESIUM HYDROXIDEMeijer, Inc.bb8ba371-f53c-1088-e053-2a95a90a4cbf2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLC00c61622-367b-0a5b-e063-6294a90a67062023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEStrategic Sourcing Services LLC003a3c0d-7a48-e44d-e063-6394a90a3f4a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp2d1be236-e136-4727-a52d-714f628800882023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d690d82-e4fb-57ad-e053-2a91aa0a38ea2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d6a8048-93e7-42e5-e053-2991aa0acabd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d7f5a38-4222-5bfb-e053-2991aa0a17e32023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDECARDINAL HEALTHaf4b6b64-97c9-a794-e053-2a95a90aaf0b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECARDINAL HEALTHaf5ddf5d-b1f5-2918-e053-2995a90a2d612023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEH E Bab998776-6b30-9f17-e053-2995a90a96cd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Babfe89c8-86f1-bd1e-e053-2995a90af7732023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEGOODSENSEa951617d-c6fa-75e0-e053-2995a90afcf82023-11-07WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKROGER COMPANYa1b04366-ff67-3bb3-e053-2a95a90a816c2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEBETTER LIVING BRANDS, LLCb9440381-df40-4bc7-e053-2995a90ae83f2023-11-07WarningsExact identifier
application number: M007
Milk of Magnesia mintMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f6027-51a0-1730-e053-2995a90a553b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83eb807-d522-4408-e053-2a95a90a79262023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f0c1c-0e90-2888-e053-2995a90a0b962023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEDOLGENCORP, INC.b6991abf-9819-701c-e053-2a95a90ac0b42023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEChain Drug Marketing Association7722145c-913c-4ed5-a9b2-a6c3430640662023-11-06WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEChain Drug Marketing Association12361478-d178-4950-9458-4e2e565655992023-11-06WarningsExact 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