FDA.reportPublic FDA data

Bisacodyl

Product NDC
0904-6748
Requested package NDC
0904-6748-80
11-digit product format
009046748
Labeler code
0904
Product ID
0904-6748_14fafe89-e4bf-4282-8a72-3bfcee7227fc
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisacodyl
Listing expiration
2026-12-31

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
6b85af55-35db-4630-8bc0-9ff4fbf5990aAvailable 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
0904-6748-17Bisacodyl1 in 1 CARTONTABLET, DELAYED RELEASE114
0904-6748-17Bisacodyl25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2514
0904-6748-60Bisacodyl100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10014
0904-6748-80Bisacodyl1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6748-17EA - Each0904-67484ad50450-99a7-40b2-99ea-4f1812c5b8c712019-02-13
0904-6748-60EA - Each0904-67485fe1e51f-a913-40d6-87f6-860c57fcac9612018-12-13
0904-6748-80EA - Each0904-674880e9234e-96db-4f38-8270-ce64e0dce73612018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6748BISACODYL TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]12Current NDC, Legacy NDC, 4 package rows20250130_6b85af55-35db-4630-8bc0-9ff4fbf5990a.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
BisacodylBISACODYLMajor Pharmaceuticals6b85af55-35db-4630-8bc0-9ff4fbf5990a2025-11-19WarningsExact identifier
ndc (package): 0904-6748-80
ndc (product): 0904-6748
ndc11 (package): 00904674880

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Delayed Release Oral TabletSCD71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Enteric Coated Oral TabletSY71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Delayed Release Oral TabletPSN6b85af55-35db-4630-8bc0-9ff4fbf5990a14
308753bisacodyl 5 MG Delayed Release Oral TabletSCD6b85af55-35db-4630-8bc0-9ff4fbf5990a14
308753bisacodyl 5 MG Enteric Coated Oral TabletSY6b85af55-35db-4630-8bc0-9ff4fbf5990a14
308753bisacodyl 5 MG Delayed Release Oral TabletPSNca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Delayed Release Oral TabletSCDca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Enteric Coated Oral TabletSYca67d5e8-d67d-44ce-adf7-cf9b2eed89d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6748-80009046748801000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0904-6748-80) 2018-12-010000-00-00NoNoCurrent