FDA.reportPublic FDA data

Dulcolax Stimulant Laxative

Product NDC
41167-0400
11-digit product format
411670400
Labeler code
41167
Product ID
41167-0400_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
2019-04-14
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
41167-0400-1Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED108
41167-0400-1Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0400-2Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0400-2Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0400-3Dulcolax Stimulant Laxative2 in 1 CARTONTABLET, COATED28
41167-0400-3Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0400-4Dulcolax Stimulant Laxative4 in 1 CARTONTABLET, COATED48
41167-0400-4Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0400-5Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0400-5Dulcolax Stimulant Laxative8 in 1 BLISTER PACKTABLET, COATED88
41167-0400-6Dulcolax Stimulant Laxative25 in 1 BLISTER PACKTABLET, COATED258
41167-0400-6Dulcolax Stimulant Laxative8 in 1 CARTONTABLET, COATED88
41167-0400-8Dulcolax Stimulant Laxative3 in 1 CARTONTABLET, COATED38
41167-0400-8Dulcolax Stimulant Laxative10 in 1 BLISTER PACKTABLET, COATED108
41167-0400-9Dulcolax Stimulant Laxative1 in 1 CARTONTABLET, COATED18
41167-0400-9Dulcolax Stimulant Laxative6 in 1 BLISTER PACKTABLET, COATED68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0400-2ML - Milliliter41167-0400dcc88c7f-d895-44cb-b98d-11c8a6af96c512019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0400DULCOLAX STIMULANT LAXATIVE (BISACODYL) TABLET, COATED [CHATTEM, INC.]8Current NDC, Legacy NDC, 16 package rows20250406_f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0400-1411670400011 BLISTER PACK in 1 CARTON (41167-0400-1) / 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-04-140000-00-00NoNoCurrent
41167-0400-2411670400021 BLISTER PACK in 1 CARTON (41167-0400-2) / 25 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-04-140000-00-00NoNoCurrent
41167-0400-3411670400032 BLISTER PACK in 1 CARTON (41167-0400-3) / 25 TABLET, COATED in 1 BLISTER PACK2 blister pack2019-04-140000-00-00NoNoCurrent
41167-0400-4411670400044 BLISTER PACK in 1 CARTON (41167-0400-4) / 25 TABLET, COATED in 1 BLISTER PACK4 blister pack2019-06-030000-00-00NoNoCurrent
41167-0400-5411670400051 BLISTER PACK in 1 CARTON (41167-0400-5) / 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2019-04-140000-00-00NoNoCurrent
41167-0400-6411670400068 BLISTER PACK in 1 CARTON (41167-0400-6) / 25 TABLET, COATED in 1 BLISTER PACK8 blister pack2019-04-140000-00-00NoNoCurrent
41167-0400-8411670400083 BLISTER PACK in 1 CARTON (41167-0400-8) / 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2019-05-010000-00-00NoNoCurrent
41167-0400-9411670400091 BLISTER PACK in 1 CARTON (41167-0400-9) / 6 TABLET, COATED in 1 BLISTER PACK1 blister pack2022-06-010000-00-00NoNoCurrent