FDA.reportPublic FDA data

Bisacodyl

Product NDC
0904-6748
Requested package NDC
0904-6748-17
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

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. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0904-6748-17
ndc (product): 0904-6748
ndc11 (package): 00904674817

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

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6748-17009046748171 BLISTER PACK in 1 CARTON (0904-6748-17) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2018-12-010000-00-00NoNoCurrent