FDA.reportPublic FDA data

Bisacodyl Laxative

Product NDC
13709-328
11-digit product format
137090328
Labeler code
13709
Product ID
13709-328_3908d3b4-6bfd-dc73-e063-6294a90a5088
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl Laxative Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-23
Substance
BISACODYL
Active strength
10 mg/1.8g
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 Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/1.8g

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
35cb0386-a662-6893-e063-6294a90aa71aAvailable 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
13709-328-01Bisacodyl Laxative30 in 1 CARTONSUPPOSITORY303
13709-328-01Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-02Bisacodyl Laxative5 in 1 CARTONSUPPOSITORY53
13709-328-02Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative10 in 1 CARTONSUPPOSITORY103

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 13 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
application number: M015
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal PadsWITCH HAZELWalmart, Inc.6dd8d3d9-5109-4869-917b-9521e9ba1ed02025-07-14WarningsExact identifier
application number: M015
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
application number: M015
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
application number: M015
medicated wipesWITCH HAZELMeijer Distribution Inc.ba0f3f9a-95d1-4d8a-86d1-2c25c945118c2025-07-11WarningsExact identifier
application number: M015
hemorrhoidal padsWITCH HAZELMeijer Distribution Inc.53e39d22-a89e-4f95-8c64-abeb50f72ce72025-07-11WarningsExact identifier
application number: M015
INVIGOR OHLIDOCAINENatureplex LLC7c7b536d-e41a-4017-9df9-982e2e9cfe4e2025-07-10WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF ANTI-ITCHHYDROCORTISONEHaleon US Holdings LLCd6148d77-ef6f-4552-b5ba-43b429923f192025-07-07WarningsExact identifier
application number: M015
Rectal Care CreamRECTAL CARE CREAMAllegiant Healthce585082-ad39-4b6f-a756-0d9a81a13eb82025-07-07WarningsExact identifier
application number: M015
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
application number: M015
ndc (product): 13709-328
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
application number: M015
TN Dickinsons Medicated Cooling Foam Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.deca8ae2-53a3-4c90-aa10-45354e2cdab82025-06-27WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
application number: M015
Phenylephrine HemorrhoidalHEMORRHOIDAL SUPPOSITORIESNeilmed Pharmaceuticals Inc.35ccb320-e902-3d1a-e063-6294a90a68d52025-06-20WarningsExact identifier
application number: M015
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
application number: M015
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLStrategic Sourcing Services LLCfb3bc359-b06b-4995-aa68-0117a639dff22025-06-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN35cb0386-a662-6893-e063-6294a90aa71a3
198509bisacodyl 10 MG Rectal SuppositorySCD35cb0386-a662-6893-e063-6294a90aa71a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-328-011370903280130 BLISTER PACK in 1 CARTON (13709-328-01) / 1.8 g in 1 BLISTER PACK30 blister pack2025-05-23NoNoCurrent
13709-328-02137090328025 BLISTER PACK in 1 CARTON (13709-328-02) / 1.8 g in 1 BLISTER PACK5 blister pack2025-05-23NoNoCurrent
13709-328-031370903280310 BLISTER PACK in 1 CARTON (13709-328-03) / 1.8 g in 1 BLISTER PACK10 blister pack2025-05-23NoNoCurrent