FDA.reportPublic FDA data

Walgreens Gentle Laxative

Product NDC
0363-0468
11-digit product format
003630468
Labeler code
0363
Product ID
0363-0468_5516a38a-04a5-943d-e063-6394a90a4a7b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl Suppository
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-24
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

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
20c43036-830b-0e1d-e063-6394a90adf5fAvailable 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
0363-0468-04Walgreens Gentle Laxative1 in 1 CARTONSUPPOSITORY13
0363-0468-04Walgreens Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY43
0363-0468-08Walgreens Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY43
0363-0468-08Walgreens Gentle Laxative2 in 1 CARTONSUPPOSITORY23
0363-0468-30Walgreens Gentle Laxative5 in 1 CARTONSUPPOSITORY53
0363-0468-30Walgreens Gentle Laxative6 in 1 BLISTER PACKSUPPOSITORY63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0468WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]3Current NDC, 6 package rows20250303_20c43036-830b-0e1d-e063-6394a90adf5f.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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN20c43036-830b-0e1d-e063-6394a90adf5f3
198509bisacodyl 10 MG Rectal SuppositorySCD20c43036-830b-0e1d-e063-6394a90adf5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0468-04003630468041 BLISTER PACK in 1 CARTON (0363-0468-04) / 4 SUPPOSITORY in 1 BLISTER PACK1 blister pack2025-02-24NoNoCurrent
0363-0468-08003630468082 BLISTER PACK in 1 CARTON (0363-0468-08) / 4 SUPPOSITORY in 1 BLISTER PACK2 blister pack2025-02-24NoNoCurrent
0363-0468-30003630468305 BLISTER PACK in 1 CARTON (0363-0468-30) / 6 SUPPOSITORY in 1 BLISTER PACK5 blister pack2025-02-24NoNoCurrent