FDA.reportPublic FDA data

Dulcolax Simulant Laxative

Product NDC
41167-0101
11-digit product format
411670101
Labeler code
41167
Product ID
41167-0101_4c5644fe-e922-4f9d-b80a-c18ac5454309
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-12
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
Dulcolax Simulant Laxative
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209613Internal RxNorm lookup
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
d285651b-7ccc-4ae5-a862-7a38dffefa28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0101-0Dulcolax Simulant Laxative8 in 1 BLISTER PACKTABLET, FILM COATED88
41167-0101-0Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-1Dulcolax Simulant Laxative10 in 1 BLISTER PACKTABLET, FILM COATED108
41167-0101-1Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-2Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-2Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-3Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-3Dulcolax Simulant Laxative2 in 1 CARTONTABLET, FILM COATED28
41167-0101-4Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-4Dulcolax Simulant Laxative4 in 1 CARTONTABLET, FILM COATED48
41167-0101-5Dulcolax Simulant Laxative8 in 1 CARTONTABLET, FILM COATED88
41167-0101-5Dulcolax Simulant Laxative25 in 1 BLISTER PACKTABLET, FILM COATED258
41167-0101-6Dulcolax Simulant Laxative3 in 1 CARTONTABLET, FILM COATED38
41167-0101-6Dulcolax Simulant Laxative10 in 1 BLISTER PACKTABLET, FILM COATED108
41167-0101-7Dulcolax Simulant Laxative1 in 1 CARTONTABLET, FILM COATED18
41167-0101-7Dulcolax Simulant Laxative6 in 1 BLISTER PACKTABLET, FILM COATED68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0101DULCOLAX SIMULANT LAXATIVE (BISACODYL) TABLET, FILM COATED [CHATTEM, INC.]8Current NDC, Legacy NDC, 16 package rows20250501_d285651b-7ccc-4ae5-a862-7a38dffefa28.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
Dulcolax Simulant LaxativeBISACODYLChattem, Inc.d285651b-7ccc-4ae5-a862-7a38dffefa282025-04-01WarningsExact identifier
ndc (product): 41167-0101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNd285651b-7ccc-4ae5-a862-7a38dffefa288
209613Dulcolax 5 MG Delayed Release Oral TabletPSNd285651b-7ccc-4ae5-a862-7a38dffefa288
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBDd285651b-7ccc-4ae5-a862-7a38dffefa288
308753bisacodyl 5 MG Delayed Release Oral TabletSCDd285651b-7ccc-4ae5-a862-7a38dffefa288
308753bisacodyl 5 MG Enteric Coated Oral TabletSYd285651b-7ccc-4ae5-a862-7a38dffefa288
209613Dulcolax 5 MG Delayed Release Oral TabletSYd285651b-7ccc-4ae5-a862-7a38dffefa288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0101-0411670101001 BLISTER PACK in 1 CARTON (41167-0101-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-1411670101011 BLISTER PACK in 1 CARTON (41167-0101-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-2411670101021 BLISTER PACK in 1 CARTON (41167-0101-2) / 25 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-3411670101032 BLISTER PACK in 1 CARTON (41167-0101-3) / 25 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-4411670101044 BLISTER PACK in 1 CARTON (41167-0101-4) / 25 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-5411670101058 BLISTER PACK in 1 CARTON (41167-0101-5) / 25 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-6411670101063 BLISTER PACK in 1 CARTON (41167-0101-6) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2021-02-120000-00-00NoNoCurrent
41167-0101-7411670101071 BLISTER PACK in 1 CARTON (41167-0101-7) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-06-01NoNoCurrent