Gentle Laxative Bisacodyl

Product NDC: 13709-321
11-digit product format: 137090321
Labeler code: 13709
Product ID: 13709-321_2beb19bf-3d35-ed44-e063-6294a90a7eef
Type: HUMAN OTC DRUG
Nonproprietary name: Gentle Laxative Bisacodyl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: NeilMed Pharmaceuticals Inc
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-08-24
Substance: BISACODYL
Active strength: 10 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: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	13709-321		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13709-321	13709-321-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Gentle Laxative Bisacodyl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISACODYL	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10X0709Y6I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198509	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
03b3733a-4d78-149f-e063-6294a90a6518	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13709-321-01	Gentle Laxative Bisacodyl	6 in 1 BLISTER PACK	SUPPOSITORY	6		2
13709-321-01	Gentle Laxative Bisacodyl	5 in 1 CARTON	SUPPOSITORY	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13709-321	GENTLE LAXATIVE BISACODYL SUPPOSITORY [NEILMED PHARMACEUTICALS INC]	2	Current NDC, 2 package rows	20250119_03b3733a-4d78-149f-e063-6294a90a6518.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family wellness	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	FRONT PHARMACEUTICAL PLC	cfdd61e3-e12e-491c-b2a8-90fae19e8870	2023-10-27	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM	FRONT PHARMACEUTICAL PLC	eb1785f4-5876-443b-b175-9b59d65d1a48	2023-10-26	Warnings	Exact identifier application number: M015
CVS Health Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	FRONT PHARMACEUTICAL PLC	cb448d78-553c-4e65-80c5-d4b31d7b3661	2023-10-26	Warnings	Exact identifier application number: M015
Family Wellness	PHENYLEPHRINE HCL, PETROLATUM, MINERAL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bfa195d7-d87f-43b5-bbf1-7ec3a451de05	2023-10-25	Warnings	Exact identifier application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots	LIDOCAINE	CVS PHARMACY, INC	82aa128a-44cd-4907-b0f7-8a31e086d3e6	2023-10-25	Warnings	Exact identifier application number: M015
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier application number: M015
Assured Bikini Smooth Cream	LIDOCAINE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fb9ddde3-3f40-467e-8aff-26570144f0fc	2023-10-25	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Cardinal Health 110, LLC. dba Leader	85a51d5c-679e-1959-e053-2a91aa0a76d5	2023-10-25	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fde9cd90-d63c-4058-b46e-511fecea36ec	2023-10-24	Warnings	Exact identifier application number: M015
Lidocaine 5%	LIDOCAINE	Apnar Pharma LP	ceedce20-5723-5a9a-e053-2a95a90a17a1	2023-10-21	Warnings	Exact identifier application number: M015
Numquick Topical Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	3f64cbd3-6745-4397-9767-3adc3b301e0e	2023-10-19	Warnings	Exact identifier application number: M015
Healquick Tattoo Balm	PETROLATUM	Unit Dose, Ltd.	96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86	2023-10-19	Warnings	Exact identifier application number: M015
Numpot Topical Anesthetic	LIDOCAINE, PETROLATUM	Unit Dose, Ltd.	9143b50b-7d76-4545-aa2e-1bb77ffb44ae	2023-10-19	Warnings	Exact identifier application number: M015
Microcaine Topical Analgesic	LIDOCAINE	Unit Dose, Ltd.	5e8fa8b5-0524-4201-91e1-83e59a8f0415	2023-10-19	Warnings	Exact identifier application number: M015
Numstick	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	127bbd87-5402-4da2-abf3-dac6367735ec	2023-10-18	Warnings	Exact identifier application number: M015
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminE	HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE	NeilMed pharmaceuticals Inc.	076b5021-8ba0-0204-e063-6294a90a3337	2023-10-11	Warnings	Exact identifier application number: M015
Zensa Numbing Gel	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Alera Skin Care Products Inc.	065a6eec-3896-0da8-e063-6394a90a849d	2023-09-27	Warnings	Exact identifier application number: M015

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	03b3733a-4d78-149f-e063-6294a90a6518	2
198509	bisacodyl 10 MG Rectal Suppository	SCD	03b3733a-4d78-149f-e063-6294a90a6518	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
13709-321-01	13709032101	5 BLISTER PACK in 1 CARTON (13709-321-01) / 6 CAPSULE in 1 BLISTER PACK / 1 SUPPOSITORY in 1 CAPSULE	5 blister pack	2023-08-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NeilMed Gentle Laxative Suppositories Bisacodyl USP 10mg	NeilMed Pharmaceuticals Inc \| NeilMed Pharmaceuticals Inc.	2025-01-17	HUMAN OTC DRUG LABEL	2