stimulant laxative enteric coated

Product NDC
85766-148
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
stimulant laxative enteric coatedBISACODYLSportpharm LLC3123e0d3-b1af-45db-bea7-d349c155407d2026-02-06WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have • stomach pain, nausea, vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk • it may cause stomach discomfort, faintness and cramps Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

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

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
85766-148-00857660148001000 TABLET in 1 BOTTLE (85766-148-00) 1000 tablet2026-02-06NoNoCurrent
85766-148-0185766014801100 TABLET in 1 BOTTLE (85766-148-01) 100 tablet2026-02-06NoNoCurrent
85766-148-0285766014802200 TABLET in 1 BOTTLE (85766-148-02) 200 tablet2026-02-06NoNoCurrent
85766-148-25857660148251 BLISTER PACK in 1 CARTON (85766-148-25) / 25 TABLET in 1 BLISTER PACK1 blister pack2026-02-06NoNoCurrent
85766-148-268576601482625 TABLET in 1 BOTTLE (85766-148-26) 25 tablet2026-02-06NoNoCurrent