FDA.reportPublic FDA data

Laxative

Product NDC
0363-6760
11-digit product format
003636760
Labeler code
0363
Product ID
0363-6760_7e6c3cdc-ad3d-4fcc-b477-a262a311bfad
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative
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
22ac8924-5c2c-412a-a127-bee1c46ea462Available 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
0363-6760-01Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1514
0363-6760-01Laxative2 in 1 CARTONTABLET, DELAYED RELEASE214
0363-6760-52Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1514
0363-6760-52Laxative6 in 1 CARTONTABLET, DELAYED RELEASE614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6760LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [WALGREEN COMPANY]13Current NDC, Legacy NDC, 4 package rows20250302_22ac8924-5c2c-412a-a127-bee1c46ea462.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
LaxativeBISACODYLWalgreen Company22ac8924-5c2c-412a-a127-bee1c46ea4622026-02-26WarningsExact identifier
ndc (product): 0363-6760

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN22ac8924-5c2c-412a-a127-bee1c46ea46214
308753bisacodyl 5 MG Delayed Release Oral TabletSCD22ac8924-5c2c-412a-a127-bee1c46ea46214
308753bisacodyl 5 MG Enteric Coated Oral TabletSY22ac8924-5c2c-412a-a127-bee1c46ea46214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6760-01003636760012 BLISTER PACK in 1 CARTON (0363-6760-01) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2015-09-160000-00-00NoNoCurrent
0363-6760-52003636760526 BLISTER PACK in 1 CARTON (0363-6760-52) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2015-09-160000-00-00NoNoCurrent