FDA.reportPublic FDA data

C-Lax Laxative

Product NDC
59779-676
11-digit product format
597790676
Labeler code
59779
Product ID
59779-676_c59b5cac-81c2-4965-a466-6d6fe9d8222e
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
C-Lax Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-676-13C-Lax Laxative250 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE25016
59779-676-52C-Lax Laxative6 in 1 CARTONTABLET, DELAYED RELEASE616
59779-676-52C-Lax Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-676-13EA - Each59779-67635a9ec5c-c67c-4dce-8b04-ddc8adc151c912017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
BISACODYLACTIVE MOIETY10X0709Y6IC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30C-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656C-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TRIACETININACTIVE INGREDIENTXHX3C3X673C-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMC-LAX LAXATIVE (BISACODYL) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-676C-LAX LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [CVS PHARMACY]14Current NDC, Legacy NDC, 3 package rows20250124_46e59908-fed4-4e24-a148-ca75164d977a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN46e59908-fed4-4e24-a148-ca75164d977a16
308753bisacodyl 5 MG Delayed Release Oral TabletSCD46e59908-fed4-4e24-a148-ca75164d977a16
308753bisacodyl 5 MG Enteric Coated Oral TabletSY46e59908-fed4-4e24-a148-ca75164d977a16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-676-1359779067613250 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (59779-676-13) 2015-09-160000-00-00NoNoCurrent
59779-676-52597790676526 BLISTER PACK in 1 CARTON (59779-676-52) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK6 blister pack2015-09-160000-00-00NoNoCurrent