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 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
f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0Available 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
41167-0400-1Dulcolax 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

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 Stimulant LaxativeBISACODYLChattem, Inc.f1e4b28a-ed74-4eff-bd10-b2bfaf7483b02025-04-08WarningsExact identifier
ndc (product): 41167-0400

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