FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-107-09IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-107-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-107-09IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-107-17IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59779-107-09EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59779-107-17EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact 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
59779-107-04597790107041 BLISTER PACK in 1 CARTON (59779-107-04) / 4 SUPPOSITORY in 1 BLISTER PACK1 blister pack2014-09-18NoNoCurrent
59779-107-08597790107084 in 1 BLISTER PACKHistorical
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
59779-107-16597790107164 in 1 BLISTER PACKHistorical
59779-107-17597790107174 BLISTER PACK in 1 CARTON (59779-107-17) / 4 SUPPOSITORY in 1 BLISTER PACK (59779-107-16) 4 blister pack2014-09-180000-00-00NoNoCurrent