FDA.reportPublic FDA data

Dulcolax Laxative

Product NDC
41167-0210
11-digit product format
411670210
Labeler code
41167
Product ID
41167-0210_d39ca8c0-d92a-4c16-a35e-efa8acc21aa5
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-04
Substance
BISACODYL
Active strength
10 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 Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 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
198509Internal RxNorm lookup
209601Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
016a4920-77a7-4ac3-8d9d-fd2f564dfee6Available 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
41167-0210-1Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-1Dulcolax Laxative1 in 1 CARTONSUPPOSITORY14
41167-0210-2Dulcolax Laxative2 in 1 CARTONSUPPOSITORY24
41167-0210-2Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-3Dulcolax Laxative4 in 1 CARTONSUPPOSITORY44
41167-0210-3Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44
41167-0210-5Dulcolax Laxative7 in 1 CARTONSUPPOSITORY74
41167-0210-5Dulcolax Laxative4 in 1 BLISTER PACKSUPPOSITORY44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0210-1EA - Each41167-0210b2016e3c-efa1-4bba-b681-9b7e62ea8e6b12022-06-06
41167-0210-2EA - Each41167-0210d794afc3-6cc3-479f-9d73-d34d7132a6df12022-06-06
41167-0210-3EA - Each41167-0210a17e22f2-b481-45a1-92ea-9ff8c3dc431d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0210DULCOLAX LAXATIVE (BISACODYL) SUPPOSITORY [CHATTEM, INC.]4Current NDC, Legacy NDC, 8 package rows20250207_016a4920-77a7-4ac3-8d9d-fd2f564dfee6.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 LaxativeBISACODYLChattem, Inc.016a4920-77a7-4ac3-8d9d-fd2f564dfee62024-02-01WarningsExact identifier
ndc (product): 41167-0210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN016a4920-77a7-4ac3-8d9d-fd2f564dfee64
209601Dulcolax 10 MG Rectal SuppositoryPSN016a4920-77a7-4ac3-8d9d-fd2f564dfee64
209601bisacodyl 10 MG Rectal Suppository [Dulcolax]SBD016a4920-77a7-4ac3-8d9d-fd2f564dfee64
198509bisacodyl 10 MG Rectal SuppositorySCD016a4920-77a7-4ac3-8d9d-fd2f564dfee64
209601Dulcolax 10 MG Rectal SuppositorySY016a4920-77a7-4ac3-8d9d-fd2f564dfee64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0210-1411670210011 BLISTER PACK in 1 CARTON (41167-0210-1) / 4 SUPPOSITORY in 1 BLISTER PACK1 blister pack2019-06-040000-00-00NoNoCurrent
41167-0210-2411670210022 BLISTER PACK in 1 CARTON (41167-0210-2) / 4 SUPPOSITORY in 1 BLISTER PACK2 blister pack2019-06-040000-00-00NoNoCurrent
41167-0210-3411670210034 BLISTER PACK in 1 CARTON (41167-0210-3) / 4 SUPPOSITORY in 1 BLISTER PACK4 blister pack2019-06-040000-00-00NoNoCurrent
41167-0210-5411670210057 BLISTER PACK in 1 CARTON (41167-0210-5) / 4 SUPPOSITORY in 1 BLISTER PACK7 blister pack2019-06-040000-00-00NoNoCurrent