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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui209613, 308753

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

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