FDA.reportPublic FDA data

Dulcolax Laxative

Product NDC
41167-0222
11-digit product format
411670222
Labeler code
41167
Product ID
41167-0222_a2391b80-8592-44ff-af63-198d04d243ab
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dulcolax Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui2710428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0222-0Dulcolax Laxative1 in 1 CARTONCAPSULE, LIQUID FILLED13
41167-0222-0Dulcolax Laxative20 in 1 BOTTLECAPSULE, LIQUID FILLED203
41167-0222-1Dulcolax Laxative1 in 1 CARTONCAPSULE, LIQUID FILLED13
41167-0222-1Dulcolax Laxative72 in 1 BOTTLECAPSULE, LIQUID FILLED723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0222DULCOLAX LAXATIVE (BISACODYL) CAPSULE, LIQUID FILLED [CHATTEM, INC.]2Current NDC, 4 package rows20250406_919375cd-7646-4958-9e2b-cec2e1b2bd49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2710428bisacodyl 5 MG Oral CapsulePSN919375cd-7646-4958-9e2b-cec2e1b2bd493
2710428bisacodyl 5 MG Oral CapsuleSCD919375cd-7646-4958-9e2b-cec2e1b2bd493

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-0222-0411670222001 BOTTLE in 1 CARTON (41167-0222-0) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-02-21NoNoCurrent
41167-0222-1411670222011 BOTTLE in 1 CARTON (41167-0222-1) / 72 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-11-03NoNoCurrent