FDA.reportPublic FDA data

CVS Gentle Laxative

Product NDC
59779-107
Requested package NDC
59779-107-09
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-10759779-107-09IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-10759779-107-09IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59779-10759779-107-09EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Gentle Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c6a651a-f062-4784-9d82-156f9f745223Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
59779-107-172024-01-259d75b9cf-eff0-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-092024-01-159d75b9cf-f008-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-092023-01-309d75b9cf-f008-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-172023-01-309d75b9cf-eff0-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-092021-02-049d75b9cf-f008-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-172021-02-049d75b9cf-eff0-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 16 ct
59779-107-092020-01-319d75b9cf-f008-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 8 ct
59779-107-172020-01-319d75b9cf-eff0-f424-e053-dadaa90a57ceCVS Pharmacy ® Gentle Laxatives 16 ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-107-16CVS Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY412
59779-107-17CVS Gentle Laxative4 in 1 CARTONSUPPOSITORY412
59779-107-08CVS Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY49
59779-107-09CVS Gentle Laxative2 in 1 CARTONSUPPOSITORY29
59779-107-04CVS Gentle Laxative1 in 1 CARTONSUPPOSITORY14
59779-107-04CVS Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ICVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]4
BISACODYLACTIVE MOIETY10X0709Y6ICVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]4
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]4
BISACODYLACTIVE INGREDIENT10X0709Y6ICVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]2
BISACODYLACTIVE MOIETY10X0709Y6ICVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]2
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233CVS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-107CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]10Current NDC, Legacy NDC, 2 package rows20241227_0cca1516-fc8d-4471-bd37-a6230fd225e2.zip
59779-107CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]7Current NDC, Legacy NDC, 2 package rows20241227_9c6a651a-f062-4784-9d82-156f9f745223.zip
59779-107CVS GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [CVS PHARMACY]2Current NDC, Legacy NDC, 2 package rows20241227_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 1 of 44 · 878 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsExact identifier
application number: M007
BisacodylBISACODYLKROGER COMPANYa13a8eec-3652-8c57-e053-2995a90aaebf2026-09-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
application number: M007
fiber laxativePSYLLIUM HUSKRaritan Pharmaceuticals Inc22e927bd-5734-424e-8870-1aaa18f1265e2026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC5e5749f7-074e-4bbc-9f33-5090e603fdb42026-09-08WarningsExact identifier
application number: M007
Bisacodyl Stimulant LaxativeBISACODYLRaritan Pharmaceuticals Incb99c1a6d-3034-4822-8540-210179c068572026-09-08WarningsExact identifier
application number: M007
Daily Fiber Sugar FreePSYLLIUM HUSKRaritan Pharmaceuticals Inc9c4c41d8-a2d5-4168-9e97-9f9d47fc5e632026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC56c7f197-f01a-4611-a761-cda18da6eed02026-09-08WarningsExact identifier
application number: M007
Sennosides 8.6 mgSENNOSIDESMorepen Bio Inc562c9f11-0ba1-011d-e063-6394a90a604a2026-09-05WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
application number: M007
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Senna Laxative Regular StrengthSENNOSIDESKROGER COMPANYdbb040bb-21f9-43e8-9705-689aeee4d04c2026-09-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INC44c87bbc-2507-4b87-a74b-02f4acb30cf42026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INCe6de00e6-dd81-4aab-af23-04fab261c6ff2026-09-01WarningsExact identifier
application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon FlavorMAGNESIUM CITRATEValley Medical Products LLC5a71e88c-d8cc-a8bb-e063-6294a90af4f72026-09-01WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILTHE KROGER CO.d6856f59-ccc3-40fc-9bf1-7a5394ed12da2026-09-01WarningsExact identifier
application number: M007
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Association583b64e7-e48d-6ba6-e063-6294a90ad4d72026-08-28Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN0cca1516-fc8d-4471-bd37-a6230fd225e212
198509bisacodyl 10 MG Rectal SuppositorySCD0cca1516-fc8d-4471-bd37-a6230fd225e212
198509bisacodyl 10 MG Rectal SuppositoryPSN9c6a651a-f062-4784-9d82-156f9f7452239
198509bisacodyl 10 MG Rectal SuppositorySCD9c6a651a-f062-4784-9d82-156f9f7452239
198509bisacodyl 10 MG Rectal SuppositoryPSN10a9bd9a-181b-69ba-e063-6294a90ac4584
198509bisacodyl 10 MG Rectal SuppositorySCD10a9bd9a-181b-69ba-e063-6294a90ac4584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-107-09597790107092 BLISTER PACK in 1 CARTON (59779-107-09) / 4 SUPPOSITORY in 1 BLISTER PACK (59779-107-08) 2 blister pack2014-09-180000-00-00NoNoCurrent