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
Ingredient	Strength
BISACODYL	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10X0709Y6I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198509	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58980-415-04	Stratuscare Bisacodyl	4 in 1 BOX	SUPPOSITORY	4	5
58980-415-08	Stratuscare Bisacodyl	8 in 1 BOX	SUPPOSITORY	8	5
58980-415-12	Stratuscare Bisacodyl	12 in 1 BOX	SUPPOSITORY	12	5
58980-415-16	Stratuscare Bisacodyl	1 in 1 BOX	SUPPOSITORY	1	5
58980-415-16	Stratuscare Bisacodyl	16 in 1 BLISTER PACK	SUPPOSITORY	16	5
58980-415-50	Stratuscare Bisacodyl	1 in 1 BOX	SUPPOSITORY	1	5
58980-415-50	Stratuscare Bisacodyl	50 in 1 BLISTER PACK	SUPPOSITORY	50	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-415-04	EA - Each	58980-415	22bdad97-0eaa-406a-b277-914520aefdc6	1	2020-07-13
58980-415-08	EA - Each	58980-415	1affbada-b083-4f59-a9f6-be072cad6e7b	1	2020-07-13
58980-415-12	EA - Each	58980-415	083e5cc0-cf8d-4a88-b5b9-ec9ea8374cb3	1	2019-01-24
58980-415-16	EA - Each	58980-415	1e701bdc-8861-4da3-8f26-f6532d46f36f	1	2025-05-14
58980-415-50	EA - Each	58980-415	4e87e672-3c15-47cf-924f-198eff8d65b3	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1
Bisacodyl	ACTIVE MOIETY	10X0709Y6I	STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1
HYDROGENATED SOYBEAN OIL	INACTIVE INGREDIENT	A2M91M918C	STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58980-415	STRATUSCARE BISACODYL (BISACODYL) SUPPOSITORY [STRATUS PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 7 package rows	20250418_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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	b1d903a5-1d5f-44d4-9939-a4b86e5a620d	2024-05-23	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8	2024-05-23	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	MEIJER, INC.	11fe5bd0-585a-ad8a-e063-6294a90a3ae8	2024-05-22	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Sam's West, Inc	b14d2495-1092-4063-869f-73a7e8c28708	2024-05-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d	2024-05-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	c0898583-4bbb-41d5-9e84-00cca823024f	2024-05-15	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9c986ca8-d540-49c1-b092-94c1bf837c07	2024-05-09	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	ed20d198-e935-200e-e053-2a95a90a309b	2024-05-02	Warnings	Exact identifier application number: M007
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Major Pharmaceuticals	1768b470-2808-fa46-e063-6394a90ac8d9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Stimulant laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	72f8e8d7-ee38-4bd3-8711-f11fded0cede	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	c1e9863a-c229-4694-b450-6b0e0ad37503	2024-04-30	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	96c7f8bc-be95-40d1-9977-44b7cc6582df	2024-04-22	Warnings	Exact identifier application number: M007
Pedia-Lax	MAGNESIUM HYDROXIDE	C.B. Fleet Company, Inc.	975f24d8-218c-40f4-84a5-558acf34329d	2024-04-11	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	H E B	2f9e2723-53a7-47a8-8c41-87bffc4e50dd	2024-04-09	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	H E B	d047e4e9-b8ac-498e-9fde-8af5d415edaa	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	5b8bcc6c-de03-4d73-a76f-6f4c371cf250	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	H E B	1dd2be7e-bdca-4e43-b853-3ed10b636632	2024-04-08	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	1f11cf85-b094-4ca4-8b48-2d3a9093304b	2024-04-04	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10X0709Y6I	BISACODYL	603-50-9	BISACODYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198509	bisacodyl 10 MG Rectal Suppository	PSN	795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d	5
198509	bisacodyl 10 MG Rectal Suppository	SCD	795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58980-415-04	58980041504	4 BLISTER PACK in 1 BOX (58980-415-04) / 1 SUPPOSITORY in 1 BLISTER PACK	4 blister pack	2014-05-30	0000-00-00	No	No	Current
58980-415-08	58980041508	8 BLISTER PACK in 1 BOX (58980-415-08) / 1 SUPPOSITORY in 1 BLISTER PACK	8 blister pack	2014-05-30	0000-00-00	No	No	Current
58980-415-12	58980041512	12 BLISTER PACK in 1 BOX (58980-415-12) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2014-05-30	0000-00-00	No	No	Current
58980-415-16	58980041516	16 BLISTER PACK in 1 BOX (58980-415-16) / 1 SUPPOSITORY in 1 BLISTER PACK	16 blister pack	2025-05-01		No	No	Current
58980-415-50	58980041550	50 BLISTER PACK in 1 BOX (58980-415-50) / 1 SUPPOSITORY in 1 BLISTER PACK	50 blister pack	2020-06-01		No	No	Current