Dulcolax

Product NDC: 0597-0340
11-digit product format: 005970340
Labeler code: 0597
Product ID: 0597-0340_7e3d2ba1-1ea6-62e3-d82d-a0f19a906bb3
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: 2013-08-01
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0597-0340		D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-48	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-54	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-64	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-70	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-71	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-72	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-82	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0340	0597-0340-97	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 2 · 108 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	0597-0340-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0340-54	`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	0597-0340-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0340-54	`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	0597-0340-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-97	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0340-54	`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	0597-0340-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-97	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0340-54	`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	0597-0340-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-97	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0340-54	`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	0597-0340-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-82	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-97	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0340-54	`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	0597-0340-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0340-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0340-71	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0340-72	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0340-82	`302b2466d912…`	`e7b80fea0513…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
cellacefate	INACTIVE INGREDIENT	F2O5O2OI9F	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
sorbitan monooleate	INACTIVE INGREDIENT	06XEA2VD56	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
white wax	INACTIVE INGREDIENT	7G1J5DA97F	DULCOLAX (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
0597-0340-48	00597034048	1 BLISTER PACK in 1 CARTON (0597-0340-48) > 25 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-54	00597034054	2 BLISTER PACK in 1 CARTON (0597-0340-54) > 25 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-64	00597034064	6 BLISTER PACK in 1 CARTON (0597-0340-64) > 25 TABLET, COATED in 1 BLISTER PACK	6 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-70	00597034070	4 BLISTER PACK in 1 CARTON (0597-0340-70) > 25 TABLET, COATED in 1 BLISTER PACK	4 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-71	00597034071	1 BLISTER PACK in 1 CARTON (0597-0340-71) > 10 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-72	00597034072	2 BLISTER PACK in 1 CARTON (0597-0340-72) > 15 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-82	00597034082	1 BLISTER PACK in 1 CARTON (0597-0340-82) > 8 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2013-08-01	0000-00-00	No	No	Current
0597-0340-97	00597034097	8 BLISTER PACK in 1 CARTON (0597-0340-97) > 25 TABLET, COATED in 1 BLISTER PACK	8 blister pack	2013-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dulcolax ® Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative	Boehringer Ingelheim Pharmaceuticals, Inc.	2018-12-19	HUMAN OTC DRUG LABEL	3

Dulcolax

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#