stimulant laxative enteric coated

Product NDC
85766-148
Requested package NDC
85766-148-26
11-digit product format
857660148
Labeler code
85766
Product ID
85766-148_4a23c0a6-035a-2fc5-e063-6294a90a3448
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-06
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
stimulant laxative enteric coated
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3123e0d3-b1af-45db-bea7-d349c155407dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-148-00stimulant laxative enteric coated1000 in 1 BOTTLETABLET10001
85766-148-01stimulant laxative enteric coated100 in 1 BOTTLETABLET1001
85766-148-02stimulant laxative enteric coated200 in 1 BOTTLETABLET2001
85766-148-25stimulant laxative enteric coated25 in 1 BLISTER PACKTABLET251
85766-148-25stimulant laxative enteric coated1 in 1 CARTONTABLET11
85766-148-26stimulant laxative enteric coated25 in 1 BOTTLETABLET251

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
stimulant laxative enteric coatedBISACODYLSportpharm LLC3123e0d3-b1af-45db-bea7-d349c155407d2026-02-06WarningsExact identifier
ndc (package): 85766-148-26
ndc (product): 85766-148
ndc11 (package): 85766014826

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN3123e0d3-b1af-45db-bea7-d349c155407d1
308753bisacodyl 5 MG Delayed Release Oral TabletSCD3123e0d3-b1af-45db-bea7-d349c155407d1
308753bisacodyl 5 MG Enteric Coated Oral TabletSY3123e0d3-b1af-45db-bea7-d349c155407d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-148-268576601482625 TABLET in 1 BOTTLE (85766-148-26) 25 tablet2026-02-06NoNoCurrent