FDA.reportPublic FDA data

Bisacodyl

Product NDC
0574-7050
11-digit product format
005747050
Labeler code
0574
Product ID
0574-7050_f362a4a6-01ee-46e6-941c-dad836f20029
Type
HUMAN OTC DRUG
Nonproprietary name
bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-09-01
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

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
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
7eada0fc-5f83-43da-a56f-b0f537298208Available 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
0574-7050-12Bisacodyl12 in 1 CARTONSUPPOSITORY126
0574-7050-12Bisacodyl1 in 1 BLISTER PACKSUPPOSITORY16
0574-7050-50Bisacodyl1 in 1 BLISTER PACKSUPPOSITORY16
0574-7050-50Bisacodyl50 in 1 CARTONSUPPOSITORY506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7050-12EA - Each0574-7050c123ab28-c52e-46bb-8da8-2c68be8a722512014-10-03
0574-7050-50EA - Each0574-7050b8b7568e-e63d-419b-bc81-7dad55c3874a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPBISACODYL SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7050BISACODYL SUPPOSITORY [PADAGIS US LLC]5Current NDC, Legacy NDC, 4 package rows20241012_7eada0fc-5f83-43da-a56f-b0f537298208.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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEPreferred Pharmaceuticals Inc.f8bba8cb-a111-4285-8bdb-2273a049c3bb2026-07-08WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
application number: M007
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
application number: M007
SennaSENNOSIDES 8.6 MG TABLETSAarkish Pharmaceuticals NJ Inc.564bc9a5-13b5-4cce-a349-6b2e122683ed2026-07-01WarningsExact identifier
application number: M007
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
application number: M007
ENEMEEZDOCUSATE SODIUMQuest Products, LLC0b06445d-0839-497e-bdff-e0fe224a77382026-06-30WarningsExact identifier
application number: M007
ENEMEEZ PlusDOCUSATE SODIUM AND BENZOCAINEQuest Products, LLC1670ca59-7275-4ac6-bef4-674a7b24c7b32026-06-30WarningsExact identifier
application number: M007
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens20c43036-830b-0e1d-e063-6394a90adf5f2026-06-25WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packagingbe7cab51-ce7e-465d-95db-083e69288cfd2026-06-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEVi-Jon, LLCba490c22-19f0-4887-9509-bd3d32e0f5b12026-06-24Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEKROGER COMPANYa1b0c638-6c34-1b72-e053-2995a90acc852026-06-24WarningsExact identifier
application number: M007
Womens LaxativeWOMENS LAXTIVEAllegiant Health549a11d1-a096-4c22-96b4-2d4f54f460222026-06-24WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf4259fda-19d4-087e-e053-2995a90a70812026-06-22WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMGeri-Care Pharmaceuticals, Corp3ec42148-6786-22f2-e054-00144ff8d46c2026-06-18WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
application number: M007
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
application number: M007
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN7eada0fc-5f83-43da-a56f-b0f5372982086
198509bisacodyl 10 MG Rectal SuppositorySCD7eada0fc-5f83-43da-a56f-b0f5372982086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7050-120057470501212 BLISTER PACK in 1 CARTON (0574-7050-12) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack1990-09-010000-00-00NoNoCurrent
0574-7050-500057470505050 BLISTER PACK in 1 CARTON (0574-7050-50) / 1 SUPPOSITORY in 1 BLISTER PACK50 blister pack1990-09-010000-00-00NoNoCurrent