FDA.reportPublic FDA data

Laxomil

Product NDC
55758-504
11-digit product format
557580504
Labeler code
55758
Product ID
55758-504_4d7abf05-8f42-a9a5-e063-6394a90a579d
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl 5mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Pharmadel LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-10
Substance
BISACODYL
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
Laxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup
2719716Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3999935b-d8e8-52a6-e063-6294a90aa2a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-504-01Laxomil1 in 1 CARTONTABLET, COATED12
55758-504-01Laxomil24 in 1 BLISTER PACKTABLET, COATED242

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 36 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMSam's West, Incb14d2495-1092-4063-869f-73a7e8c287082024-05-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.c0898583-4bbb-41d5-9e84-00cca823024f2024-05-15WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9c986ca8-d540-49c1-b092-94c1bf837c072024-05-09WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
application number: M007
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
application number: M007
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
application number: M007
Pedia-LaxMAGNESIUM HYDROXIDEC.B. Fleet Company, Inc.975f24d8-218c-40f4-84a5-558acf34329d2024-04-11WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
application number: M007
SennaSENNOSIDESH E Bd047e4e9-b8ac-498e-9fde-8af5d415edaa2024-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack1f11cf85-b094-4ca4-8b48-2d3a9093304b2024-04-04WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN3999935b-d8e8-52a6-e063-6294a90aa2a22
2719716Laxomil 5 MG Delayed Release Oral TabletPSN3999935b-d8e8-52a6-e063-6294a90aa2a22
2719716bisacodyl 5 MG Delayed Release Oral Tablet [Laxomil]SBD3999935b-d8e8-52a6-e063-6294a90aa2a22
308753bisacodyl 5 MG Delayed Release Oral TabletSCD3999935b-d8e8-52a6-e063-6294a90aa2a22
308753bisacodyl 5 MG Enteric Coated Oral TabletSY3999935b-d8e8-52a6-e063-6294a90aa2a22
2719716Laxomil 5 MG Delayed Release Oral TabletSY3999935b-d8e8-52a6-e063-6294a90aa2a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-504-01557580504011 BLISTER PACK in 1 CARTON (55758-504-01) / 24 TABLET, COATED in 1 BLISTER PACK1 blister pack2025-07-10NoNoCurrent