FDA.reportPublic FDA data

Senna-Lax

Product NDC
53041-159
11-digit product format
530410159
Labeler code
53041
Product ID
53041-159_dd385d1a-6a28-46fa-bebe-447985c71135
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Guardian Drug Company
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-02-02
Substance
SENNOSIDES
Active strength
8.6 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
Senna-Lax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3ee7288-986e-44a6-8aa2-05405210c875Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-159-14Senna-Lax1 in 1 CARTONTABLET14
53041-159-14Senna-Lax50 in 1 BOTTLETABLET504
53041-159-16Senna-Lax1 in 1 CARTONTABLET14
53041-159-16Senna-Lax100 in 1 BOTTLETABLET1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJXSENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
SENNOSIDESACTIVE MOIETY3FYP5M0IJXSENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-159SENNA-LAX (SENNOSIDES) TABLET [GUARDIAN DRUG COMPANY]4Current NDC, Legacy NDC, 4 package rows20241222_d3ee7288-986e-44a6-8aa2-05405210c875.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 1 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsExact identifier
application number: M007
BisacodylBISACODYLKROGER COMPANYa13a8eec-3652-8c57-e053-2995a90aaebf2026-09-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
application number: M007
fiber laxativePSYLLIUM HUSKRaritan Pharmaceuticals Inc22e927bd-5734-424e-8870-1aaa18f1265e2026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC5e5749f7-074e-4bbc-9f33-5090e603fdb42026-09-08WarningsExact identifier
application number: M007
Bisacodyl Stimulant LaxativeBISACODYLRaritan Pharmaceuticals Incb99c1a6d-3034-4822-8540-210179c068572026-09-08WarningsExact identifier
application number: M007
Daily Fiber Sugar FreePSYLLIUM HUSKRaritan Pharmaceuticals Inc9c4c41d8-a2d5-4168-9e97-9f9d47fc5e632026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC56c7f197-f01a-4611-a761-cda18da6eed02026-09-08WarningsExact identifier
application number: M007
Sennosides 8.6 mgSENNOSIDESMorepen Bio Inc562c9f11-0ba1-011d-e063-6394a90a604a2026-09-05WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
application number: M007
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Senna Laxative Regular StrengthSENNOSIDESKROGER COMPANYdbb040bb-21f9-43e8-9705-689aeee4d04c2026-09-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INC44c87bbc-2507-4b87-a74b-02f4acb30cf42026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INCe6de00e6-dd81-4aab-af23-04fab261c6ff2026-09-01WarningsExact identifier
application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon FlavorMAGNESIUM CITRATEValley Medical Products LLC5a71e88c-d8cc-a8bb-e063-6294a90af4f72026-09-01WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILTHE KROGER CO.d6856f59-ccc3-40fc-9bf1-7a5394ed12da2026-09-01WarningsExact identifier
application number: M007
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Association583b64e7-e48d-6ba6-e063-6294a90ad4d72026-08-28Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSNd3ee7288-986e-44a6-8aa2-05405210c8754
312935sennosides, USP 8.6 MG Oral TabletSCDd3ee7288-986e-44a6-8aa2-05405210c8754
312935sennosides A and B 8.6 MG Oral TabletSYd3ee7288-986e-44a6-8aa2-05405210c8754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-159-14530410159141 BOTTLE in 1 CARTON (53041-159-14) / 50 TABLET in 1 BOTTLE1 bottle2002-02-020000-00-00NoNoCurrent
53041-159-16530410159161 BOTTLE in 1 CARTON (53041-159-16) / 100 TABLET in 1 BOTTLE1 bottle2002-02-020000-00-00NoNoCurrent