FDA.reportPublic FDA data

Laxative

Product NDC
11822-0790
11-digit product format
118220790
Labeler code
11822
Product ID
11822-0790_ad1b57ad-7111-4dfe-a037-934af4500b1c
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

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
11822-0790-1Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE258
11822-0790-1Laxative2 in 1 CARTONTABLET, DELAYED RELEASE28
11822-0790-5Laxative1 in 1 CARTONTABLET, DELAYED RELEASE18
11822-0790-5Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE258
11822-0790-6Laxative1 in 1 CARTONTABLET, DELAYED RELEASE18
11822-0790-6Laxative200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0790LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [RITE AID CORPORATION]7Current NDC, Legacy NDC, 6 package rows20241206_edc31d33-0b6e-458c-9d69-859bbb58b0df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNedc31d33-0b6e-458c-9d69-859bbb58b0df8
308753bisacodyl 5 MG Delayed Release Oral TabletSCDedc31d33-0b6e-458c-9d69-859bbb58b0df8
308753bisacodyl 5 MG Enteric Coated Oral TabletSYedc31d33-0b6e-458c-9d69-859bbb58b0df8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0790-1118220790012 BLISTER PACK in 1 CARTON (11822-0790-1) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2022-11-140000-00-00NoNoCurrent
11822-0790-5118220790051 BLISTER PACK in 1 CARTON (11822-0790-5) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2022-11-140000-00-00NoNoCurrent
11822-0790-6118220790061 BOTTLE, PLASTIC in 1 CARTON (11822-0790-6) / 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2022-11-140000-00-00NoNoCurrent