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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui198509, 209601

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

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