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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	United Natural Foods, Inc. dba UNFI	cb7bc571-295f-47c2-ae93-18cba194752c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Strategic Sourcing Services LLC	e4965086-dcc0-4b34-bb30-81facf7139f3	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Valu Merchandisers Company	cd3e5836-b2f0-41f3-8623-3105c4642491	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Valu Merchandisers Company	a693f6b0-0679-4609-9ca0-dddfa4158c02	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Valu Merchandisers Company	fb358bc3-e479-42e7-8aea-a6a3676f2430	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Valu Merchandisers Company	ff539c1c-9ed3-49be-9b30-1858f12e1e90	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	United Natural Foods, Inc. dba UNFI	bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Walgreens SmoothLAX Soft Chews	MAGNESIUM HYDROXIDE	Walgreens	424e27ce-0b11-9cd2-e063-6294a90a3c21	2026-02-16	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	da013c15-3531-4dc5-b122-bfc99bc494ae	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	db1bc651-1a35-4f92-a917-c6a19f421594	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	The Kroger Co.	e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b	2026-02-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	b2ec06b3-647d-49ab-a392-6db63d96d1e3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Topco Associates LLC	5643f2e0-93e2-4c2e-90a0-fd152150d18a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Topco Associates LLC	d3cc7cb6-098e-413c-b1ad-7ebf5fa35269	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Topco Associates LLC	bc89c4bc-5207-479d-9a3b-e570b412a7ba	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	72f69aa0-381a-4e5c-975d-3a73fdc1b377	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Topco Associates LLC	e9b1fd61-c229-4529-82c2-d6ac5b076082	2026-02-13	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Pinnacle RX LLC	4abbb0e4-e005-bc4e-e063-6394a90a126a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
365 Whole Foods Market Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market, Inc.	4147cdd0-57f6-3857-e063-6394a90afecb	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Your Military Exchanges	27cff497-123c-424a-9c43-57740c00168b	2026-02-12	Warnings, Adverse reactions	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