FDA.reportPublic FDA data

Gentle Laxative Bisacodyl

Product NDC
13709-321
11-digit product format
137090321
Labeler code
13709
Product ID
13709-321_2beb19bf-3d35-ed44-e063-6294a90a7eef
Type
HUMAN OTC DRUG
Nonproprietary name
Gentle Laxative Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
NeilMed Pharmaceuticals Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-24
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
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct13709-321UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13709-32113709-321-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Gentle Laxative 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
03b3733a-4d78-149f-e063-6294a90a6518Available 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
13709-321-01Gentle Laxative Bisacodyl6 in 1 BLISTER PACKSUPPOSITORY62
13709-321-01Gentle Laxative Bisacodyl5 in 1 CARTONSUPPOSITORY52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-321GENTLE LAXATIVE BISACODYL SUPPOSITORY [NEILMED PHARMACEUTICALS INC]2Current NDC, 2 package rows20250119_03b3733a-4d78-149f-e063-6294a90a6518.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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
application number: M015
Bunnies Bum Anorectal NumbingLIDOCAINEFloCal Distributors LLC3712e151-d171-1c5d-e063-6294a90a36c02025-06-08WarningsExact identifier
application number: M015
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
application number: M015
Hemorrohoid Master CreamLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.36eccc74-107e-3914-e063-6294a90a18562025-06-06WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc36c9988b-9e61-ebbf-e063-6394a90a41142025-06-04WarningsExact identifier
application number: M015
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.36caf20d-116a-f86a-e063-6294a90a7b622025-06-04WarningsExact identifier
application number: M015
Quick NumbLIDOCAINEClinical Resolution Laboratory, Inc.351b95a6-e038-d9aa-e063-6294a90a41722025-05-29WarningsExact identifier
application number: M015
Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINERugby Laboratories Inc.f23c8cd1-98f9-41cd-84d4-cf01c2ede29a2025-05-29WarningsExact identifier
application number: M015
The Femme Fix Hemorrhoid TreatmentLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLC5217b5d9-b835-4428-a6b3-e6b2556307422025-05-27WarningsExact identifier
application number: M015
MAXOCAINE Topical Anesthetic AnorectalLIDOCAINEPRIME COMMERCE, LLC26e8c867-8cb8-4a25-91b1-da45a1edd09a2025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINEEbanel Laboratories, Inc.35107403-55ae-c627-e063-6394a90a0b5c2025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc350e4d5e-dac7-ae4e-e063-6394a90a76b42025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINE 5%Ebanel Laboratories, Inc350fd302-8fd5-5288-e063-6294a90aa3822025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc35095bed-0e91-c44a-e063-6294a90add6e2025-05-27WarningsExact identifier
application number: M015
Numb520LIDOCAINEClinical Resolution Laboratory, Inc.a0411950-c6ee-4427-acb6-3cef58b0e93e2025-05-15WarningsExact identifier
application number: M015
Numb25LIDOCAINEClinical Resolution Laboratory, Inc.cfcb839d-47b4-4925-bb30-97b64d20d2b32025-05-15WarningsExact identifier
application number: M015
Numb520LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEClinical Resolution Laboratory, Inc.65d3b614-361d-4fb9-9583-a95be754bc822025-05-15WarningsExact identifier
application number: M015
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
application number: M015
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN03b3733a-4d78-149f-e063-6294a90a65182
198509bisacodyl 10 MG Rectal SuppositorySCD03b3733a-4d78-149f-e063-6294a90a65182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-321-01137090321015 BLISTER PACK in 1 CARTON (13709-321-01) / 6 CAPSULE in 1 BLISTER PACK / 1 SUPPOSITORY in 1 CAPSULE5 blister pack2023-08-24NoNoCurrent