FDA.reportPublic FDA data

Laxacin

Product NDC
50488-0901
11-digit product format
504880901
Labeler code
50488
Product ID
50488-0901_1b45f6d1-4436-4b3a-813b-7043c0d0fad6
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Alexso, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-15
Substance
DOCUSATE SODIUM; SENNOSIDES A AND B
Active strength
50; 8.6 mg/1; 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
Laxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES A AND B8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
1B5FPI42ENInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup
2106884Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0df9abaf-3997-4dde-8003-ae3d8d07cf39Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-0901-1Laxacin100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-0901-1EA - Each50488-0901933d71c3-b01d-44ff-b256-0bee20827ae812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DOCUSATEACTIVE MOIETYM7P27195AGLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
DOCUSATEACTIVE MOIETYM7P27195AGLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SENNOSIDESACTIVE MOIETY3FYP5M0IJXLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-0901LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO, INC]8Current NDC, Legacy NDC, 1 package rows20241208_0df9abaf-3997-4dde-8003-ae3d8d07cf39.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 4 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007
Best ChoiceCALCIUM POLYCARBOPHILBEST CHOICE (VALU MERCHANDISERS COMPANY)24eb538f-abcb-4a91-b691-a8aac01c952a2026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber LaxativePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)92b46689-b5fc-41f4-91ac-535699900b392026-07-17WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.498acb19-b2f4-4af0-8996-390115c17fe02026-07-17Warnings, Adverse reactionsExact identifier
application number: M007
Best Choice Fiber TherapyMETHYLCELLULOSEBEST CHOICE (VALU MERCHANDISERS COMPANY)fab6567f-d988-43f2-a6cf-44e5b24af2792026-07-17WarningsExact identifier
application number: M007
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
application number: M007
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
application number: M007
LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6103fded-622c-4551-9f32-ca1da44683ac2026-07-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.800fa966-077d-4624-9e36-75fe8863dad02026-07-10WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSN0df9abaf-3997-4dde-8003-ae3d8d07cf398
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN0df9abaf-3997-4dde-8003-ae3d8d07cf398
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBD0df9abaf-3997-4dde-8003-ae3d8d07cf398
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD0df9abaf-3997-4dde-8003-ae3d8d07cf398
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY0df9abaf-3997-4dde-8003-ae3d8d07cf398
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SY0df9abaf-3997-4dde-8003-ae3d8d07cf398
2106884Laxacin 50 MG / 8.6 MG Oral TabletSY0df9abaf-3997-4dde-8003-ae3d8d07cf398
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSN57fca238-ba1e-4b05-abda-a8333da8132a2
2106884Laxacin 50 MG / 8.6 MG Oral TabletPSNfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN57fca238-ba1e-4b05-abda-a8333da8132a2
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBD57fca238-ba1e-4b05-abda-a8333da8132a2
2106884docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SBDfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD57fca238-ba1e-4b05-abda-a8333da8132a2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY57fca238-ba1e-4b05-abda-a8333da8132a2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SY57fca238-ba1e-4b05-abda-a8333da8132a2
2106884DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Laxacin]SYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2
2106884Laxacin 50 MG / 8.6 MG Oral TabletSY57fca238-ba1e-4b05-abda-a8333da8132a2
2106884Laxacin 50 MG / 8.6 MG Oral TabletSYfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-0901-150488090101100 TABLET in 1 BOTTLE (50488-0901-1) 100 tablet2018-10-150000-00-00NoNoCurrent