FDA.reportPublic FDA data

Gentle Laxative

Product NDC
46122-767
11-digit product format
461220767
Labeler code
46122
Product ID
46122-767_d800e618-755f-4838-a382-a9f4e6d50a25
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-01
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
2027-12-31
Current FDA listing
Yes

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
f6ce3117-dcd0-40da-81e0-b640fa49075cAvailable on FDA.report

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
46122-767-11Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE253
46122-767-11Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-767-11EA - Each46122-76725d04cf4-5249-497a-a51a-65faf819dd6812025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-767GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]2Current NDC, 2 package rows20250217_f6ce3117-dcd0-40da-81e0-b640fa49075c.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 LaxativeBISACODYLAmerisource Bergenf6ce3117-dcd0-40da-81e0-b640fa49075c2026-02-25WarningsExact identifier
ndc (product): 46122-767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNf6ce3117-dcd0-40da-81e0-b640fa49075c3
308753bisacodyl 5 MG Delayed Release Oral TabletSCDf6ce3117-dcd0-40da-81e0-b640fa49075c3
308753bisacodyl 5 MG Enteric Coated Oral TabletSYf6ce3117-dcd0-40da-81e0-b640fa49075c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-767-11461220767111 BLISTER PACK in 1 CARTON (46122-767-11) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2013-04-01NoNoCurrent