FDA.reportPublic FDA data

Dulcolax Stimulant Laxative

Product NDC
41167-0200
11-digit product format
411670200
Labeler code
41167
Product ID
41167-0200_d67a73f2-eb0f-46a1-84be-373af1406393
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-02
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 Stimulant 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
41167-0200-1Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0200-1Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED108
41167-0200-2Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0200-2Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0200-3Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0200-3Dulcolax Stimulant Laxative2 in 1 CARTONTABLET, COATED28
41167-0200-4Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0200-4Dulcolax Stimulant Laxative4 in 1 CARTONTABLET, COATED48
41167-0200-5Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0200-5Dulcolax Stimulant Laxative8 in 1 BLISTER PACKTABLET, COATED88
41167-0200-6Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0200-6Dulcolax Stimulant Laxative8 in 1 CARTONTABLET, COATED88
41167-0200-8Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED108
41167-0200-8Dulcolax Stimulant Laxative3 in 1 CARTONTABLET, COATED38
41167-0200-1Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-1Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED102
41167-0200-2Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-2Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-3Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-3Dulcolax Stimulant Laxative2 in 1 CARTONTABLET, COATED22
41167-0200-4Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-4Dulcolax Stimulant Laxative4 in 1 CARTONTABLET, COATED42
41167-0200-5Dulcolax Stimulant Laxative8 in 1 BLISTER PACKTABLET, COATED82
41167-0200-5Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED12
41167-0200-6Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED252
41167-0200-6Dulcolax Stimulant Laxative8 in 1 CARTONTABLET, COATED82
41167-0200-8Dulcolax Stimulant Laxative3 in 1 CARTONTABLET, COATED32
41167-0200-8Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0200DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]8Current NDC, Legacy NDC, 14 package rows20250406_f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0.zip
41167-0200DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]2Current NDC, Legacy NDC, 14 package rows20200905_e0dcae0f-6dca-4700-a415-de2274e6f779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
209613Dulcolax 5 MG Delayed Release Oral TabletPSNf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBDf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
308753bisacodyl 5 MG Delayed Release Oral TabletSCDf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
308753bisacodyl 5 MG Enteric Coated Oral TabletSYf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
209613Dulcolax 5 MG Delayed Release Oral TabletSYf1e4b28a-ed74-4eff-bd10-b2bfaf7483b08
308753bisacodyl 5 MG Delayed Release Oral TabletPSNe0dcae0f-6dca-4700-a415-de2274e6f7792
209613Dulcolax 5 MG Delayed Release Oral TabletPSNe0dcae0f-6dca-4700-a415-de2274e6f7792
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBDe0dcae0f-6dca-4700-a415-de2274e6f7792
308753bisacodyl 5 MG Delayed Release Oral TabletSCDe0dcae0f-6dca-4700-a415-de2274e6f7792
308753bisacodyl 5 MG Enteric Coated Oral TabletSYe0dcae0f-6dca-4700-a415-de2274e6f7792
209613Dulcolax 5 MG Delayed Release Oral TabletSYe0dcae0f-6dca-4700-a415-de2274e6f7792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0200-1411670200011 BLISTER PACK in 1 CARTON (41167-0200-1) / 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-03-010000-00-00NoNoCurrent
41167-0200-2411670200021 BLISTER PACK in 1 CARTON (41167-0200-2) / 25 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-02-150000-00-00NoNoCurrent
41167-0200-3411670200032 BLISTER PACK in 1 CARTON (41167-0200-3) / 25 TABLET, COATED in 1 BLISTER PACK2 blister pack2019-01-020000-00-00NoNoCurrent
41167-0200-4411670200044 BLISTER PACK in 1 CARTON (41167-0200-4) / 25 TABLET, COATED in 1 BLISTER PACK4 blister pack2019-01-020000-00-00NoNoCurrent
41167-0200-5411670200051 BLISTER PACK in 1 CARTON (41167-0200-5) / 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-02-250000-00-00NoNoCurrent
41167-0200-6411670200068 BLISTER PACK in 1 CARTON (41167-0200-6) / 25 TABLET, COATED in 1 BLISTER PACK8 blister pack2019-04-110000-00-00NoNoCurrent
41167-0200-8411670200083 BLISTER PACK in 1 CARTON (41167-0200-8) / 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2019-01-020000-00-00NoNoCurrent