Dulcolax

Product NDC: 0597-0052
11-digit product format: 005970052
Labeler code: 0597
Product ID: 0597-0052_513ccca1-1a82-167a-fc3d-91c9487da860
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2002-04-01
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 10 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0597-0052		D	Discontinued by firm	2026-08-07
excluded package	package	0597-0052	0597-0052-16	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0052	0597-0052-28	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0052	0597-0052-34	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0052	0597-0052-38	D	Discontinued by firm	2026-08-07
excluded package	package	0597-0052	0597-0052-44	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 · 72 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	0597-0052-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0052-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0052-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0052-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0052-44	`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	0597-0052-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0052-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0052-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0052-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0052-44	`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	0597-0052-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0052-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0052-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0052-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0052-44	`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	0597-0052-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0052-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0052-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0052-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0052-44	`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	0597-0052-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0052-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0052-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0052-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0052-44	`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	0597-0052-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0052-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0052-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0052-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0052-44	`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	0597-0052-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0052-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0052-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0052-38	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0052-44	`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	0597-0052-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0052-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0052-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0052-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0052-44	`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	0597-0052-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0052-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0052-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0052-38	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0052-44	`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	0597-0052-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0052-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0052-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0052-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0597-0052-44	`ad56d346431e…`	`cc804d4bbf1e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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) SUPPOSITORY [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) SUPPOSITORY [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	DULCOLAX (BISACODYL) SUPPOSITORY [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
HYDROGENATED PALM KERNEL OIL	INACTIVE INGREDIENT	FM8D1RE2VP	DULCOLAX (BISACODYL) SUPPOSITORY [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1
bisacodyl	ACTIVE MOIETY	10X0709Y6I	DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1
HYDROGENATED PALM KERNEL OIL	INACTIVE INGREDIENT	FM8D1RE2VP	DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, 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
198509	bisacodyl 10 MG Rectal Suppository	PSN	1bf775a9-bd9e-41a6-acef-9a3795fbf25c	1
209601	Dulcolax 10 MG Rectal Suppository	PSN	1bf775a9-bd9e-41a6-acef-9a3795fbf25c	1
209601	bisacodyl 10 MG Rectal Suppository [Dulcolax]	SBD	1bf775a9-bd9e-41a6-acef-9a3795fbf25c	1
198509	bisacodyl 10 MG Rectal Suppository	SCD	1bf775a9-bd9e-41a6-acef-9a3795fbf25c	1
209601	Dulcolax 10 MG Rectal Suppository	SY	1bf775a9-bd9e-41a6-acef-9a3795fbf25c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0052-16	00597005216	4 BLISTER PACK in 1 CARTON (0597-0052-16) > 4 SUPPOSITORY in 1 BLISTER PACK	4 blister pack	2002-04-01	0000-00-00	No	No	Current
0597-0052-28	00597005228	7 BLISTER PACK in 1 CARTON (0597-0052-28) > 4 SUPPOSITORY in 1 BLISTER PACK	7 blister pack	2002-04-01	0000-00-00	No	No	Current
0597-0052-34	00597005234	1 BLISTER PACK in 1 CARTON (0597-0052-34) > 4 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	2002-04-01	0000-00-00	No	No	Current
0597-0052-38	00597005238	2 BLISTER PACK in 1 CARTON (0597-0052-38) > 4 SUPPOSITORY in 1 BLISTER PACK	2 blister pack	2002-04-01	0000-00-00	No	No	Current
0597-0052-44	00597005244	1 BLISTER PACK in 1 CARTON (0597-0052-44) > 1 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	2002-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dulcolax ® Bisacodyl (USP) 10 mg Suppository/Stimulant Laxative	Boehringer Ingelheim Pharmaceuticals, Inc.	2018-12-18	HUMAN OTC DRUG LABEL	4
Dulcolax® Suppository	Physicians Total Care, Inc.	2011-02-01	HUMAN OTC DRUG LABEL	1