Dulcolax

Product NDC: 0597-0012
Requested package NDC: 0597-0012-37
11-digit product format: 005970012
Labeler code: 0597
Product ID: 0597-0012_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: 2001-10-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0597-0012	0597-0012-37	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
acacia	INACTIVE INGREDIENT	5C5403N26O	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
cellacefate	INACTIVE INGREDIENT	F2O5O2OI9F	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
cellacefate	INACTIVE INGREDIENT	F2O5O2OI9F	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
cellacefate	INACTIVE INGREDIENT	F2O5O2OI9F	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
diacetylated monoglycerides	INACTIVE INGREDIENT	5Z17386USF	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
dibutyl phthalate	INACTIVE INGREDIENT	2286E5R2KE	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
kaolin	INACTIVE INGREDIENT	24H4NWX5CO	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, 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
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, 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 [MECHANICAL SERVANTS, INC.]	1
sorbitan monooleate	INACTIVE INGREDIENT	06XEA2VD56	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, 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 [PHYSICIANS TOTAL CARE, INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, 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
white wax	INACTIVE INGREDIENT	7G1J5DA97F	DULCOLAX (BISACODYL) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
white wax	INACTIVE INGREDIENT	7G1J5DA97F	DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]	1

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	2913bcab-0cef-4796-9726-5906f4ec63f8	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	PSN	2913bcab-0cef-4796-9726-5906f4ec63f8	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	PSN	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1
209613	bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]	SBD	2913bcab-0cef-4796-9726-5906f4ec63f8	1
209613	bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]	SBD	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	2913bcab-0cef-4796-9726-5906f4ec63f8	1
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	2913bcab-0cef-4796-9726-5906f4ec63f8	1
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	SY	2913bcab-0cef-4796-9726-5906f4ec63f8	1
209613	Dulcolax 5 MG Delayed Release Oral Tablet	SY	eac116c1-d109-4c01-8cd4-ba27ddd2ce40	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0012-37	00597001237	2 BLISTER PACK in 1 CARTON (0597-0012-37) > 15 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2001-10-01	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 ®	Mechanical Servants, Inc. \| Boehringer Ingelheim Promeco S.A. de C.V.	2012-01-06	HUMAN OTC DRUG LABEL	1
Dulcolax ® Tablets	Physicians Total Care, Inc.	2011-11-04	HUMAN OTC DRUG LABEL	1