FDA.reportPublic FDA data

Senna-Lax

Product NDC
53041-159
Requested package NDC
53041-159-16
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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
application number: M007
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
application number: M007
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
application number: M007
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
application number: M007
SennaSENNARugby Laboratories41d53783-7ac2-411c-b9bf-afd87b3af30d2026-04-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI95bae7bf-f240-4674-9e3c-640a603fdc352026-04-15WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.a4b442f1-d5a6-4cbf-b371-1f6639634f802026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.267c434d-3034-491b-b4b1-1d0cbacb16152026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B84116db2-a7b7-460a-a5e5-8558bd4247812026-04-02WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
application number: M007
Castor OilCASTOR OILSTRATEGIC SOURCING SERVICES4db6736f-416a-f142-e063-6394a90ab08f2026-04-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEFarmacias De Similares TX LLC4e6a64a0-e453-709b-e063-6294a90a74432026-04-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals93ef6486-0930-41e3-a2c6-44af7e37e98b2026-03-31WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact 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
53041-159-16530410159161 BOTTLE in 1 CARTON (53041-159-16) / 100 TABLET in 1 BOTTLE1 bottle2002-02-020000-00-00NoNoCurrent