FDA.reportPublic FDA data

Bisacodyl

Product NDC
57896-443
11-digit product format
578960443
Labeler code
57896
Product ID
57896-443_41d6e645-b654-726f-e063-6394a90a101b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
GERI-CARE PHARMACEUTICAL CORP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
BISACODYL
Active strength
10 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-443-12fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-443-05fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57896-443-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-443-1286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-443-0586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57896-443-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-443-12bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-443-05bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57896-443-01bd6a592717d7…303034d00443…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 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
198509Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a747a57a-028e-70ea-e053-2a95a90ac184Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57896-443-012022-11-23Bisacodyl Suppositories 443
57896-443-012022-11-23Bisacodyl Suppositories 443
57896-443-052022-11-23Bisacodyl Suppositories 443
57896-443-052022-11-23Bisacodyl Suppositories 443
57896-443-122022-11-23Bisacodyl Suppositories 443
57896-443-122022-11-23Bisacodyl Suppositories 443
57896-443-012022-01-28Bisacodyl Suppositories 443
57896-443-012022-01-28Bisacodyl Suppositories 443
57896-443-052022-01-28Bisacodyl Suppositories 443
57896-443-052022-01-28Bisacodyl Suppositories 443
57896-443-122022-01-28Bisacodyl Suppositories 443
57896-443-122022-01-28Bisacodyl Suppositories 443

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-443-01Bisacodyl20 in 1 CARTONSUPPOSITORY206
57896-443-05Bisacodyl10 in 1 CARTONSUPPOSITORY106
57896-443-12Bisacodyl2 in 1 CARTONSUPPOSITORY26
57896-443-55Bisacodyl5 in 1 BLISTER PACKSUPPOSITORY56
57896-443-66Bisacodyl6 in 1 BLISTER PACKSUPPOSITORY66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-443-05EA - Each57896-44341c7bf1c-6922-4f95-9b3a-d556aaef79c412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-443BISACODYL SUPPOSITORY [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 5 package rows20231031_a747a57a-028e-70ea-e053-2a95a90ac184.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
BisacodylBISACODYLGERI-CARE PHARMACEUTICAL CORPa747a57a-028e-70ea-e053-2a95a90ac1842025-10-23WarningsExact identifier
ndc (product): 57896-443

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNa747a57a-028e-70ea-e053-2a95a90ac1846
198509bisacodyl 10 MG Rectal SuppositorySCDa747a57a-028e-70ea-e053-2a95a90ac1846
198509bisacodyl 10 MG Rectal SuppositoryPSNa199ea53-20b3-4aae-a3f4-265b50c96de51
198509bisacodyl 10 MG Rectal SuppositorySCDa199ea53-20b3-4aae-a3f4-265b50c96de51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-443-015789604430120 BLISTER PACK in 1 CARTON (57896-443-01) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) 20 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-055789604430510 BLISTER PACK in 1 CARTON (57896-443-05) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) 10 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-12578960443122 BLISTER PACK in 1 CARTON (57896-443-12) / 6 SUPPOSITORY in 1 BLISTER PACK (57896-443-66) 2 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-55578960443555 in 1 BLISTER PACKHistorical
57896-443-66578960443666 in 1 BLISTER PACKHistorical