STIMULANT LAXATIVE

Product NDC: 72476-845
Requested package NDC: 72476-845-25
11-digit product format: 724760845
Labeler code: 72476
Product ID: 72476-845_ee27d9ab-05bb-59df-e053-2a95a90a0abd
Type: HUMAN OTC DRUG
Nonproprietary name: BISACODYL
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: RETAIL BUSINESS SERVICES, LLC
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-30
Marketing end: 0000-00-00
Substance: BISACODYL
Active strength: 5 mg/1
Pharmacologic classes: Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	72476-845	72476-845-25	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72476-845-25	2024-01-30	C162847	48780-1	1030e365-6c00-111a-e063-dadaa90a10e2	CARE ONE GENTLE LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72476-845-25	STIMULANT LAXATIVE	25 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	25		5
72476-845-25	STIMULANT LAXATIVE	1 in 1 PACKAGE	TABLET, DELAYED RELEASE	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72476-845	STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [RETAIL BUSINESS SERVICES, LLC]	5	Legacy NDC, 2 package rows	20241222_4bb375a0-8ec3-4769-9802-832b8a280e7d.zip

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	4bb375a0-8ec3-4769-9802-832b8a280e7d	5
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	4bb375a0-8ec3-4769-9802-832b8a280e7d	5
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	4bb375a0-8ec3-4769-9802-832b8a280e7d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72476-845-25	72476084525	1 BLISTER PACK in 1 PACKAGE (72476-845-25) > 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2021-03-30	0000-00-00	No	No	Current