FDA.reportPublic FDA data

Gentle Laxative

Product NDC
70000-0538
Requested package NDC
70000-0538-1
11-digit product format
700000538
Labeler code
70000
Product ID
70000-0538_0bdcdd75-0629-bd6b-e063-6394a90a6d38
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
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
2026-12-31
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
2026-12-31

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
97b83b7a-1a41-71e7-e053-2995a90ac640Available 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
70000-0538-1Gentle Laxative100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0538-1EA - Each70000-053858274d1b-f6e6-419e-bcff-67b3180961b912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0538GENTLE LAXATIVE (BISACODYL) TABLET [CARDINAL HEALTH]5Current NDC, Legacy NDC, 1 package rows20231207_97b83b7a-1a41-71e7-e053-2995a90ac640.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 HEALTH97b83b7a-1a41-71e7-e053-2995a90ac6402023-12-06WarningsExact identifier
ndc (package): 70000-0538-1
ndc (product): 70000-0538
ndc11 (package): 70000053801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN97b83b7a-1a41-71e7-e053-2995a90ac6405
308753bisacodyl 5 MG Delayed Release Oral TabletSCD97b83b7a-1a41-71e7-e053-2995a90ac6405
308753bisacodyl 5 MG Enteric Coated Oral TabletSY97b83b7a-1a41-71e7-e053-2995a90ac6405

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0538-170000053801100 TABLET in 1 BOTTLE (70000-0538-1) 100 tablet2019-11-010000-00-00NoNoCurrent