Womens Gentle Laxative

Product NDC: 53943-676
Requested package NDC: 53943-676-01
11-digit product format: 539430676
Labeler code: 53943
Product ID: 53943-676_608196c5-e62f-43d3-b6fd-48ac42dca632
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Discount Drug Mart
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-12-20
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	53943-676	53943-676-01	D	Discontinued by firm		2026-11-10

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

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-676-01	Womens Gentle Laxative	2 in 1 CARTON	TABLET, DELAYED RELEASE	2		7
53943-676-01	Womens Gentle Laxative	15 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	15		7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-676	WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [DISCOUNT DRUG MART]	6	Legacy NDC, 2 package rows	20241121_c768b404-e31c-4966-962b-e718d32edbb0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10X0709Y6I	BISACODYL	603-50-9	BISACODYL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN	c768b404-e31c-4966-962b-e718d32edbb0	7
308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD	c768b404-e31c-4966-962b-e718d32edbb0	7
308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY	c768b404-e31c-4966-962b-e718d32edbb0	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-676-01	53943067601	2 BLISTER PACK in 1 CARTON (53943-676-01) > 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK	2 blister pack	2019-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Mart 44-676A-Delisted	Discount Drug Mart \| LNK International, Inc.	2025-11-15	HUMAN OTC DRUG LABEL	7