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

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 1B5FPI42EN
Rxcui998740, 2106884

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

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