CVS Gentle Laxative

Product NDC: 59779-107
11-digit product format: 597790107
Labeler code: 59779
Product ID: 59779-107_48644ef1-6fed-54f6-e063-6394a90af209
Type: HUMAN OTC DRUG
Nonproprietary name: Bisacodyl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: CVS Pharmacy
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-18
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: 2027-12-31
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59779-107-09	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59779-107-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59779-107-09	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59779-107-17	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59779-107-09	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59779-107-17	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: CVS Gentle Laxative
Listing expiration: 2027-12-31

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
9c6a651a-f062-4784-9d82-156f9f745223	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
59779-107-17	2024-01-25	9d75b9cf-eff0-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-09	2024-01-15	9d75b9cf-f008-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-09	2023-01-30	9d75b9cf-f008-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-17	2023-01-30	9d75b9cf-eff0-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-09	2021-02-04	9d75b9cf-f008-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-17	2021-02-04	9d75b9cf-eff0-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-09	2020-01-31	9d75b9cf-f008-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-17	2020-01-31	9d75b9cf-eff0-f424-e053-dadaa90a57ce	CVS Pharmacy ® Gentle Laxatives 16 ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59779-107-16	CVS Gentle Laxative	4 in 1 BLISTER PACK	SUPPOSITORY	4	12
59779-107-17	CVS Gentle Laxative	4 in 1 CARTON	SUPPOSITORY	4	12
59779-107-08	CVS Gentle Laxative	4 in 1 BLISTER PACK	SUPPOSITORY	4	9
59779-107-09	CVS Gentle Laxative	2 in 1 CARTON	SUPPOSITORY	2	9
59779-107-04	CVS Gentle Laxative	1 in 1 CARTON	SUPPOSITORY	1	4
59779-107-04	CVS Gentle Laxative	4 in 1 BLISTER PACK	SUPPOSITORY	4	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	4
BISACODYL	ACTIVE MOIETY	10X0709Y6I	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	4
PALM KERNEL OIL	INACTIVE INGREDIENT	B0S90M0233	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	4
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	2
BISACODYL	ACTIVE MOIETY	10X0709Y6I	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	2
PALM KERNEL OIL	INACTIVE INGREDIENT	B0S90M0233	CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-107	CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]	10	Current NDC, Legacy NDC, 2 package rows	20241227_0cca1516-fc8d-4471-bd37-a6230fd225e2.zip
59779-107	CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]	7	Current NDC, Legacy NDC, 2 package rows	20241227_9c6a651a-f062-4784-9d82-156f9f745223.zip
59779-107	CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]	2	Current NDC, Legacy NDC, 2 package rows	20241227_10a9bd9a-181b-69ba-e063-6294a90ac458.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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Extra Strength	DOCUSATE SODIUM	MEIJER, INC.	e43bd2ed-17c7-4530-af72-81a7ad70069c	2023-10-12	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Care One (Retail Business Services, LLC.)	9adaec97-43e3-48f2-96c8-c508b693676c	2023-10-05	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	TopCo Associates, LLC	83aeb90a-ab00-4e26-aa44-5259dce59018	2021-04-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	9fbe783e-ddd9-445a-852a-00f4ad754880	2021-04-20	Warnings	Exact identifier application number: M007
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	Warnings	Exact identifier application number: M007

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	0cca1516-fc8d-4471-bd37-a6230fd225e2	12
198509	bisacodyl 10 MG Rectal Suppository	SCD	0cca1516-fc8d-4471-bd37-a6230fd225e2	12
198509	bisacodyl 10 MG Rectal Suppository	PSN	9c6a651a-f062-4784-9d82-156f9f745223	9
198509	bisacodyl 10 MG Rectal Suppository	SCD	9c6a651a-f062-4784-9d82-156f9f745223	9
198509	bisacodyl 10 MG Rectal Suppository	PSN	10a9bd9a-181b-69ba-e063-6294a90ac458	4
198509	bisacodyl 10 MG Rectal Suppository	SCD	10a9bd9a-181b-69ba-e063-6294a90ac458	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-107-04	59779010704	1 BLISTER PACK in 1 CARTON (59779-107-04) / 4 SUPPOSITORY in 1 BLISTER PACK	1 blister pack	2014-09-18		No	No	Current
59779-107-08	59779010708	4 in 1 BLISTER PACK						Historical
59779-107-09	59779010709	2 BLISTER PACK in 1 CARTON (59779-107-09) / 4 SUPPOSITORY in 1 BLISTER PACK (59779-107-08)	2 blister pack	2014-09-18	0000-00-00	No	No	Current
59779-107-16	59779010716	4 in 1 BLISTER PACK						Historical
59779-107-17	59779010717	4 BLISTER PACK in 1 CARTON (59779-107-17) / 4 SUPPOSITORY in 1 BLISTER PACK (59779-107-16)	4 blister pack	2014-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy ® Gentle Laxatives 16 ct	CVS Pharmacy \| Unipack LLC	2026-01-14	HUMAN OTC DRUG LABEL	12
CVS Pharmacy ® Gentle Laxatives 8 ct	CVS Pharmacy \| Unipack LLC	2026-01-14	HUMAN OTC DRUG LABEL	9
CVS Pharmacy ® Gentle Laxatives 4 ct	CVS Pharmacy \| Unipack LLC	2026-01-14	HUMAN OTC DRUG LABEL	4