FDA.reportPublic FDA data

Stratuscare Bisacodyl

Product NDC
58980-415
11-digit product format
589800415
Labeler code
58980
Product ID
58980-415_2fb66f5b-068d-4125-a66e-670ee944891b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Stratus Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-30
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
Stratuscare Bisacodyl
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
795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2dAvailable 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
58980-415-04Stratuscare Bisacodyl4 in 1 BOXSUPPOSITORY45
58980-415-08Stratuscare Bisacodyl8 in 1 BOXSUPPOSITORY85
58980-415-12Stratuscare Bisacodyl12 in 1 BOXSUPPOSITORY125
58980-415-16Stratuscare Bisacodyl1 in 1 BOXSUPPOSITORY15
58980-415-16Stratuscare Bisacodyl16 in 1 BLISTER PACKSUPPOSITORY165
58980-415-50Stratuscare Bisacodyl1 in 1 BOXSUPPOSITORY15
58980-415-50Stratuscare Bisacodyl50 in 1 BLISTER PACKSUPPOSITORY505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-415-04EA - Each58980-41522bdad97-0eaa-406a-b277-914520aefdc612020-07-13
58980-415-08EA - Each58980-4151affbada-b083-4f59-a9f6-be072cad6e7b12020-07-13
58980-415-12EA - Each58980-415083e5cc0-cf8d-4a88-b5b9-ec9ea8374cb312019-01-24
58980-415-16EA - Each58980-4151e701bdc-8861-4da3-8f26-f6532d46f36f12025-05-14
58980-415-50EA - Each58980-4154e87e672-3c15-47cf-924f-198eff8d65b312025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BisacodylACTIVE INGREDIENT10X0709Y6ISTRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]1
BisacodylACTIVE MOIETY10X0709Y6ISTRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]1
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CSTRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-415STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]5Current NDC, Legacy NDC, 7 package rows20250418_795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d.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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d5
198509bisacodyl 10 MG Rectal SuppositorySCD795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-415-04589800415044 BLISTER PACK in 1 BOX (58980-415-04) / 1 SUPPOSITORY in 1 BLISTER PACK4 blister pack2014-05-300000-00-00NoNoCurrent
58980-415-08589800415088 BLISTER PACK in 1 BOX (58980-415-08) / 1 SUPPOSITORY in 1 BLISTER PACK8 blister pack2014-05-300000-00-00NoNoCurrent
58980-415-125898004151212 BLISTER PACK in 1 BOX (58980-415-12) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2014-05-300000-00-00NoNoCurrent
58980-415-165898004151616 BLISTER PACK in 1 BOX (58980-415-16) / 1 SUPPOSITORY in 1 BLISTER PACK16 blister pack2025-05-01NoNoCurrent
58980-415-505898004155050 BLISTER PACK in 1 BOX (58980-415-50) / 1 SUPPOSITORY in 1 BLISTER PACK50 blister pack2020-06-01NoNoCurrent