FDA.reportPublic FDA data

Laxative

Product NDC
69168-489
11-digit product format
691680489
Labeler code
69168
Product ID
69168-489_364d3ed4-210a-4e17-94e2-0add8116a2ac
Type
HUMAN OTC DRUG
Nonproprietary name
Laxative
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Allegiant Health
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-31
Substance
DEACETYLBISACODYL
Active strength
5 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEACETYLBISACODYL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R09078E41YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
596b11de-cf17-4c55-8638-49f387e5fac4Available on FDA.report

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 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
SENNA TIMESENNOSIDESBryant Ranch Prepackbdcf37fc-3938-4d3f-b669-35c6939eac4f2026-07-10WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-489-0369168048903250 TABLET, SUGAR COATED in 1 BOTTLE (69168-489-03) 2026-07-31NoNoCurrent
69168-489-3269168048932100 TABLET, SUGAR COATED in 1 BOTTLE (69168-489-32) 2026-07-31NoNoCurrent
69168-489-92691680489921 BLISTER PACK in 1 CARTON (69168-489-92) / 25 TABLET, SUGAR COATED in 1 BLISTER PACK1 blister pack2026-07-31NoNoCurrent