FDA.reportPublic FDA data

Walgreens Gentle Laxative

Product NDC
0363-0466
11-digit product format
003630466
Labeler code
0363
Product ID
0363-0466_485ea50e-b62b-cbb9-e063-6394a90a1cdf
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl Suppository
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-18
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
2027-12-31
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0363-0466-31IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0363-0466-31IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0363-0466-31IInactivated by FDAbd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0363-0466-31IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0363-0466-09IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0363-0466-31EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0363-0466-09EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Walgreens Gentle Laxative
Listing expiration
2027-12-31

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
d094ba43-7404-43c4-b907-41ab6d02a3c3Available 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, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
0363-0466-312022-12-199d75b9d0-15b2-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 30ct
0363-0466-312022-01-289d75b9d0-15b2-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 30ct
0363-0466-092020-11-039d75b9d1-279c-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 8ct
0363-0466-312020-11-039d75b9d0-15b2-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 30ct
0363-0466-092020-01-319d75b9d1-279c-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 8ct
0363-0466-312020-01-319d75b9d0-15b2-f424-e053-dadaa90a57ceWalgreens ® Gentle Laxative 30ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0466-08Walgreens Gentle Laxative2 in 1 PACKAGESUPPOSITORY27
0363-0466-08Walgreens Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY47
0363-0466-04Walgreens Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY46
0363-0466-04Walgreens Gentle Laxative1 in 1 PACKAGESUPPOSITORY16
0363-0466-30Walgreens Gentle Laxative5 in 1 PACKAGESUPPOSITORY56
0363-0466-30Walgreens Gentle Laxative6 in 1 CARTRIDGESUPPOSITORY66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0466-08EA - Each0363-046648dc80d4-fd27-476d-9e73-ba1db087052b12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0466WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]6Current NDC, Legacy NDC, 2 package rows20241227_d094ba43-7404-43c4-b907-41ab6d02a3c3.zip
0363-0466WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20241227_015e41d2-7543-4210-8345-626f5ae5f81d.zip
0363-0466WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20241227_2c30de62-b5d2-4905-90a1-a2f9a339fb27.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 19 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMarlex Pharmaceuticals Inc5ca287a3-c4f6-402d-978e-cd1328bdbc472025-11-21WarningsExact identifier
application number: M007
SAMS WESTPSYLLIUM HUSKSAM'S WEST INC2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac02025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association440a96bb-9e68-bdcc-e063-6294a90a67932025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association4277b174-4ce5-4950-8e9b-75e3c019a8f32025-11-20WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9237a-7895-388d-e053-2991aa0a92b02025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9305b-2997-49d3-e053-2991aa0a1fa12025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3c8f5b69-56f2-4e9d-e054-00144ff88e882025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3cdf1975-2607-14f5-e054-00144ff8d46c2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDERITE AID PHARMACY60284706-445f-f795-e053-2a91aa0a0a122025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp9f588e9b-56c5-4426-89fc-7b83e2d0ad1a2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFact Productsaebbdd10-0650-6efe-e053-2a95a90a0ab22025-11-19WarningsExact identifier
application number: M007
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
application number: M007
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
application number: M007
Topco Fiber Therapy Sugar FreePSYLLIUM HUSKTOPCO ASSOCIATES LLC2c61e73e-b3f7-4ab2-8bda-e65a2c0b35602025-11-10WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact identifier
application number: M007
up and up fiber therapyPSYLLIUM HUSKTarget Corporation674753ee-1174-4c06-9ed3-a090b338a39e2025-11-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNd094ba43-7404-43c4-b907-41ab6d02a3c37
198509bisacodyl 10 MG Rectal SuppositorySCDd094ba43-7404-43c4-b907-41ab6d02a3c37
198509bisacodyl 10 MG Rectal SuppositoryPSN015e41d2-7543-4210-8345-626f5ae5f81d6
198509bisacodyl 10 MG Rectal SuppositoryPSN2c30de62-b5d2-4905-90a1-a2f9a339fb276
198509bisacodyl 10 MG Rectal SuppositorySCD015e41d2-7543-4210-8345-626f5ae5f81d6
198509bisacodyl 10 MG Rectal SuppositorySCD2c30de62-b5d2-4905-90a1-a2f9a339fb276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0466-04003630466041 BLISTER PACK in 1 PACKAGE (0363-0466-04) / 4 SUPPOSITORY in 1 BLISTER PACK1 blister pack2020-11-040000-00-00NoNoCurrent
0363-0466-08003630466082 BLISTER PACK in 1 PACKAGE (0363-0466-08) / 4 SUPPOSITORY in 1 BLISTER PACK2 blister pack2014-09-18NoNoCurrent
0363-0466-09003630466092 BLISTER PACK in 1 PACKAGE (0363-0466-09) > 40 mg in 1 BLISTER PACK (0363-0466-08) 2 blister pack2014-09-180000-00-00NoNoCurrent
0363-0466-30003630466305 CARTRIDGE in 1 PACKAGE (0363-0466-30) / 6 SUPPOSITORY in 1 CARTRIDGE5 cartridge2014-09-18NoNoCurrent
0363-0466-31003630466315 CARTRIDGE in 1 PACKAGE (0363-0466-31) > 60 mg in 1 CARTRIDGE (0363-0466-30) 5 cartridge2014-09-180000-00-00NoNoCurrent