FDA.reportPublic FDA data

Bisacodyl

Product NDC
68016-688
11-digit product format
680160688
Labeler code
68016
Product ID
68016-688_12bba10e-970d-443e-93fe-796395cc7093
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
Marketing end
2027-01-31
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
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
Bisacodyl

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
71215710-f33d-4e01-a543-fc46b5ce5137Available 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
68016-688-10Bisacodyl1 in 1 CARTONTABLET, DELAYED RELEASE115
68016-688-10Bisacodyl100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10015
68016-688-25Bisacodyl25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515
68016-688-25Bisacodyl1 in 1 CARTONTABLET, DELAYED RELEASE115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-688-10EA - Each68016-688c126788f-a50c-499b-a339-fa4039c0be9712022-06-06
68016-688-25EA - Each68016-6887c9c90b5-0d17-4c0a-ab7a-bb12893e3a8212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-688BISACODYL TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM]14Current NDC, Legacy NDC, 4 package rows20250428_71215710-f33d-4e01-a543-fc46b5ce5137.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYLChain Drug Consortium71215710-f33d-4e01-a543-fc46b5ce51372025-07-21WarningsExact identifier
ndc (product): 68016-688

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN71215710-f33d-4e01-a543-fc46b5ce513715
308753bisacodyl 5 MG Delayed Release Oral TabletSCD71215710-f33d-4e01-a543-fc46b5ce513715
308753bisacodyl 5 MG Enteric Coated Oral TabletSY71215710-f33d-4e01-a543-fc46b5ce513715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-688-10680160688101 BOTTLE, PLASTIC in 1 CARTON (68016-688-10) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2002-03-252027-01-31NoNoCurrent
68016-688-25680160688251 BLISTER PACK in 1 CARTON (68016-688-25) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-252027-01-31NoNoCurrent