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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2710428Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
919375cd-7646-4958-9e2b-cec2e1b2bd49Available on FDA.report

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

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.919375cd-7646-4958-9e2b-cec2e1b2bd492026-02-26WarningsExact identifier
ndc (product): 41167-0222

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