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 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
edc31d33-0b6e-458c-9d69-859bbb58b0dfAvailable 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
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

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
LaxativeBISACODYLRite Aid Corporationedc31d33-0b6e-458c-9d69-859bbb58b0df2025-12-15WarningsExact identifier
ndc (product): 11822-0790

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