Dulcolax Pink

Product NDC: 0597-0335
11-digit product format: 005970335
Labeler code: 0597
Product ID: 0597-0335_bfdf8a35-ca5b-684e-9fab-69edcfb16281
Type: HUMAN OTC DRUG
Nonproprietary name: bisacodyl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-02-25
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0597-0335		D	Discontinued by firm	2026-08-07
excluded package	package	0597-0335	0597-0335-02	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0335	0597-0335-29	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0335	0597-0335-34	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0335	0597-0335-79	D	Discontinued by firm	2026-08-07

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 · 60 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	0597-0335-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0335-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0335-29	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0335-02	`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	0597-0335-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0335-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0335-29	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0335-02	`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	0597-0335-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0335-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0335-29	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0335-02	`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	0597-0335-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0335-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0335-29	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0335-02	`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	0597-0335-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0335-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0335-29	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0335-02	`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	0597-0335-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0335-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0335-29	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0335-02	`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	0597-0335-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0335-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0335-29	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0335-02	`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	0597-0335-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0335-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0335-29	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0335-02	`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	0597-0335-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0335-79	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0335-29	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0335-02	`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	0597-0335-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0335-79	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0335-29	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0335-02	`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	0597-0335-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0597-0335-79	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0597-0335-29	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0597-0335-02	`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	0597-0335-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0597-0335-79	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0597-0335-29	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0597-0335-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
calcium carbonate	INACTIVE INGREDIENT	H0G9379FGK	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
D&C Red NO. 27	INACTIVE INGREDIENT	2LRS185U6K	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
FD&C Blue NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
FD&C Yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
polyvinyl acetate phthalate	INACTIVE INGREDIENT	58QVG85GW3	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
sodium alginate	INACTIVE INGREDIENT	C269C4G2ZQ	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	DULCOLAX PINK (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]	1

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
0597-0335-02	00597033502	1 BLISTER PACK in 1 CARTON (0597-0335-02) > 8 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2016-02-25	0000-00-00	No	No	Current
0597-0335-29	00597033529	2 BLISTER PACK in 1 CARTON (0597-0335-29) > 15 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2016-02-25	0000-00-00	No	No	Current
0597-0335-34	00597033534	1 BLISTER PACK in 1 CARTON (0597-0335-34) > 25 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2016-02-25	0000-00-00	No	No	Current
0597-0335-79	00597033579	6 BLISTER PACK in 1 CARTON (0597-0335-79) > 15 TABLET, COATED in 1 BLISTER PACK	6 blister pack	2016-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dulcolax® Pink ™ tablets Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative	Boehringer Ingelheim Pharmaceuticals Inc.	2018-12-18	HUMAN OTC DRUG LABEL	3

Dulcolax Pink

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#