FDA.reportPublic FDA data

Gentle Laxative

Product NDC
70000-0221
11-digit product format
700000221
Labeler code
70000
Product ID
70000-0221_9f9f4a7c-7619-4b60-872f-95a8da742824
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Gentle 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
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
a82d21a9-1c40-447d-a880-4804e889459aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0221-1Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE117
70000-0221-1Gentle Laxative10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1017
70000-0221-2Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE117
70000-0221-2Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2517
70000-0221-3Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2517
70000-0221-3Gentle Laxative7 in 1 CARTONTABLET, DELAYED RELEASE717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0221-1EA - Each70000-02217750207f-5a5a-49d1-95a7-b880750cca5812019-08-06
70000-0221-2EA - Each70000-0221113ed0dd-4565-4d79-9497-0a9172f3709b12019-08-06
70000-0221-3EA - Each70000-022184a31adf-7c40-4991-af0c-7764608eb68e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0221GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]16Current NDC, Legacy NDC, 6 package rows20250323_a82d21a9-1c40-447d-a880-4804e889459a.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
Gentle LaxativeBISACODYLCardinal Health 110, LLC. DBA Leadera82d21a9-1c40-447d-a880-4804e889459a2026-06-09WarningsExact identifier
ndc (product): 70000-0221

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNa82d21a9-1c40-447d-a880-4804e889459a17
308753bisacodyl 5 MG Delayed Release Oral TabletSCDa82d21a9-1c40-447d-a880-4804e889459a17
308753bisacodyl 5 MG Enteric Coated Oral TabletSYa82d21a9-1c40-447d-a880-4804e889459a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0221-1700000221011 BLISTER PACK in 1 CARTON (70000-0221-1) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent
70000-0221-2700000221021 BLISTER PACK in 1 CARTON (70000-0221-2) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent
70000-0221-3700000221037 BLISTER PACK in 1 CARTON (70000-0221-3) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK7 blister pack2002-03-250000-00-00NoNoCurrent