WOMENS GENTLE LAXATIVE

Product NDC: 61715-039
11-digit product format: 617150039
Labeler code: 61715
Product ID: 61715-039_ecc01437-3b42-4caf-804f-acc5dc958fcc
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Preferred Plus (Kinray)
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-08-02
Marketing end: 2022-12-30
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	61715-039		D	Discontinued by firm		2026-10-05
excluded package	package	61715-039	61715-039-30	D	Discontinued by firm		2026-10-05

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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	61715-039-30	`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	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
BISACODYL	ACTIVE MOIETY	10X0709Y6I	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [PREFERRED PLUS (KINRAY)]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61715-039-30	61715003930	2 BLISTER PACK in 1 CARTON (61715-039-30) > 15 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2010-08-02	2022-12-30	No	No	Current

WOMENS GENTLE LAXATIVE

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#