FDA.reportPublic FDA data

WOMENS GENTLE LAXATIVE

Product NDC
69842-089
11-digit product format
698420089
Labeler code
69842
Product ID
69842-089_2dff3d94-3171-df85-e063-6294a90a05b7
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CVS HEALTH CORP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-24
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
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-089-52302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-089-52ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-089-520efc9e666f02…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
WOMENS GENTLE LAXATIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 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
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a95073f3-e1d6-d291-e053-2a95a90aefeaAvailable 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-089-522025-02-13C16284748780-12cef2736-b559-d83d-e063-dadaa90ab31f151R CVS BISACODYL WOMEN'S GENTLE LAXATIVE 69842-089
69842-089-522025-01-30C16284748780-12cef2736-b559-d83d-e063-dadaa90ab31f151R CVS BISACODYL WOMEN'S GENTLE LAXATIVE 69842-089

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-089-52WOMENS GENTLE LAXATIVE25 in 1 BLISTER PACKTABLET, COATED253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-089-52EA - Each69842-089e775cf63-9fb0-49ba-b1fc-e4ae339d76c012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-089WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, COATED [CVS HEALTH CORP]3Current NDC, Legacy NDC, 1 package rows20250215_a95073f3-e1d6-d291-e053-2a95a90aefea.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 18 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHILLIPS FRESH MINT MILK OF MAGNESIAPHILLIPS FRESH MINT MILK OF MAGNESIABayer HealthCare LLC.0a59f9c3-c14e-2824-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
application number: M007
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
application number: M007
PHILLIPS ORIGINAL MILK OF MAGNESIAPHILLIPS ORIGINAL MILK OF MAGNESIABayer HealthCare LLC.0a57bb45-d4f7-443b-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
application number: M007
Gentle Laxative Stimulant LaxativeBISACODYLQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)bcd3c07d-bd83-4452-9736-35c85db30c152025-12-03WarningsExact identifier
application number: M007
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
application number: M007
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
application number: M007
CDMA Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION62bbcaf2-1d0c-485f-9159-685700aa34182025-12-03WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
application number: M007
Magnesium CitrateEPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON4 Visions LLC44fe65d0-ee46-1d95-e063-6294a90abb712025-12-02WarningsExact identifier
application number: M007
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
application number: M007
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
application number: M007
Walgreens Fiber TherapyMETHYLCELLULOSEWALGREENS CO.6401a2c3-5869-4898-81db-3cd7151ca69a2025-11-25WarningsExact identifier
application number: M007
Walgreens Senna LaxativeSENNOSIDESWALGREENS CO.a95bd796-d85e-4599-bbb1-2170088fa9372025-11-25WarningsExact identifier
application number: M007
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNa95073f3-e1d6-d291-e053-2a95a90aefea3
308753bisacodyl 5 MG Delayed Release Oral TabletSCDa95073f3-e1d6-d291-e053-2a95a90aefea3
308753bisacodyl 5 MG Enteric Coated Oral TabletSYa95073f3-e1d6-d291-e053-2a95a90aefea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-089-526984200895225 TABLET, COATED in 1 BLISTER PACK (69842-089-52) 2020-08-240000-00-00NoNoCurrent