Gentle and Effective Laxative

Product NDC: 55312-190
11-digit product format: 553120190
Labeler code: 55312
Product ID: 55312-190_307bf5b4-c34d-4673-a0e6-edf3ff85bec0
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Western Family Foods, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-08
Marketing end: 2019-12-31
Substance: BISACODYL
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55312-190		D	Discontinued by firm		2026-10-15
excluded package	package	55312-190	55312-190-25	D	Discontinued by firm		2026-10-15

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 1 · 24 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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`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	55312-190-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55312-190-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55312-190-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
BISACODYL	ACTIVE MOIETY	10X0709Y6I	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED (BISACODYL) TABLET, COATED [WESTERN FAMILY FOODS, INC.]	2

Gentle and Effective Laxative

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#