FDA.reportPublic FDA data

Stimulant Laxative Plus Stool Softener

Product NDC
0536-1248
11-digit product format
005361248
Labeler code
0536
Product ID
0536-1248_5c8f314a-16ca-4856-9cd1-f6760cd938a5
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 50 mg and Sennosides 8.6 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-22
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 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
Stimulant Laxative Plus Stool Softener
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1
DOCUSATE SODIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5afd8eb-d35d-44ab-897d-1d41c98ca138Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1248-01Stimulant Laxative Plus Stool Softener100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
0536-1248-10Stimulant Laxative Plus Stool Softener1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1248-01EA - Each0536-124808914e23-fb7a-4b54-984a-a846bc8e77b912020-02-13
0536-1248-10EA - Each0536-1248b50e2bcb-0359-4534-98b7-3d9ed55f256612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1248STIMULANT LAXATIVE PLUS STOOL SOFTENER (DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG) TABLET, FILM COATED [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20241222_f5afd8eb-d35d-44ab-897d-1d41c98ca138.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
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNb25b8a28-5e00-4a20-9ca3-7ed494fc45406
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDb25b8a28-5e00-4a20-9ca3-7ed494fc45406
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYb25b8a28-5e00-4a20-9ca3-7ed494fc45406
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4c02fcec-6bb7-4497-96c5-0d809209dd173
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNf5afd8eb-d35d-44ab-897d-1d41c98ca1383
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4c02fcec-6bb7-4497-96c5-0d809209dd173
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDf5afd8eb-d35d-44ab-897d-1d41c98ca1383
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4c02fcec-6bb7-4497-96c5-0d809209dd173
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYf5afd8eb-d35d-44ab-897d-1d41c98ca1383
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN12f613e4-c919-4cc4-a445-eb30039ae45f1
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD12f613e4-c919-4cc4-a445-eb30039ae45f1
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY12f613e4-c919-4cc4-a445-eb30039ae45f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1248-0100536124801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1248-01) 2019-10-220000-00-00NoNoCurrent
0536-1248-10005361248101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1248-10) 2019-10-220000-00-00NoNoCurrent