Bisacodyl

Product NDC: 58118-7927
11-digit product format: 581187927
Labeler code: 58118
Product ID: 58118-7927_f97e277d-2fb1-4fad-845a-a1d5541dad73
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Clinical Solutions Wholesale
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2008-10-24
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 5 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58118-7927		I	Inactivated by FDA	2026-10-12
excluded package	package	58118-7927	58118-7927-0	I	Inactivated by FDA	2026-10-12
excluded package	package	58118-7927	58118-7927-3	I	Inactivated by FDA	2026-10-12
excluded package	package	58118-7927	58118-7927-6	I	Inactivated by FDA	2026-10-12
excluded package	package	58118-7927	58118-7927-8	I	Inactivated by FDA	2026-10-12
excluded package	package	58118-7927	58118-7927-9	I	Inactivated by FDA	2026-10-12

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-7927-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-7927-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-7927-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-7927-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-7927-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-7927-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-7927-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-7927-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-7927-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-7927-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-7927-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-7927-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-7927-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-7927-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-7927-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-7927-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-7927-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-7927-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-7927-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-7927-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-7927-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-7927-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-7927-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-7927-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-7927-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-7927-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-7927-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-7927-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-7927-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-7927-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-7927-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-7927-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-7927-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-7927-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-7927-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-7927-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-7927-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-7927-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-7927-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-7927-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-7927-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-7927-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-7927-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-7927-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-7927-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-7927-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-7927-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-7927-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-7927-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-7927-3	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
58118-7927-0	Bisacodyl Enteric Coated Tablet
58118-7927-3	Bisacodyl Enteric Coated Tablet
58118-7927-6	Bisacodyl Enteric Coated Tablet
58118-7927-8	Bisacodyl Enteric Coated Tablet
58118-7927-9	Bisacodyl Enteric Coated Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58118-7927-0	BisacodylEnteric Coated	1 in 1 PACKAGE	TABLET, COATED	1	1
58118-7927-3	BisacodylEnteric Coated	30 in 1 BOTTLE	TABLET, COATED	30	1
58118-7927-6	BisacodylEnteric Coated	60 in 1 BOTTLE	TABLET, COATED	60	1
58118-7927-8	BisacodylEnteric Coated	30 in 1 BLISTER PACK	TABLET, COATED	30	1
58118-7927-9	BisacodylEnteric Coated	90 in 1 BOTTLE	TABLET, COATED	90	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
AMMONIUM NONOXYNOL-4 SULFATE	INACTIVE INGREDIENT	9HIA70O4J0	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-7927	BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]	1	Legacy NDC, 5 package rows	20140716_f97e277d-2fb1-4fad-845a-a1d5541dad73.zip

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
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	f97e277d-2fb1-4fad-845a-a1d5541dad73	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	f97e277d-2fb1-4fad-845a-a1d5541dad73	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	f97e277d-2fb1-4fad-845a-a1d5541dad73	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58118-7927-0	58118792700	1 in 1 PACKAGE	Historical
58118-7927-3	58118792703	30 in 1 BOTTLE	Historical
58118-7927-6	58118792706	60 in 1 BOTTLE	Historical
58118-7927-8	58118792708	30 in 1 BLISTER PACK	Historical
58118-7927-9	58118792709	90 in 1 BOTTLE	Historical