FDA.reportPublic FDA data

Gentle Laxative

Product NDC
0363-0327
11-digit product format
003630327
Labeler code
0363
Product ID
0363-0327_7f62dacb-792e-4541-be7a-531d2fc7d26e
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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

Additional Listing Data#

Finished product
Yes
Brand name base
Gentle Laxative
Listing expiration
2026-12-31

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
0363-0327-03Gentle Laxative10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1025
0363-0327-03Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE125
0363-0327-06Gentle Laxative200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE20025
0363-0327-12Gentle Laxative4 in 1 CARTONTABLET, DELAYED RELEASE425
0363-0327-12Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2525
0363-0327-36Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE125
0363-0327-36Gentle Laxative4 in 1 BLISTER PACKTABLET, DELAYED RELEASE425
0363-0327-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE125
0363-0327-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0327-06EA - Each0363-0327f8c7ea1b-5214-4166-ac12-84d987f33f2612012-07-24
0363-0327-12EA - Each0363-03277e707368-d9e7-48de-b4de-2445cd0bc8e212012-07-24
0363-0327-56EA - Each0363-03278ad4c44b-4446-4b13-a8c6-8112b09a574e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
BISACODYLACTIVE MOIETY10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
ACACIAINACTIVE INGREDIENT5C5403N26OGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
SHELLACINACTIVE INGREDIENT46N107B71OGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
SUCROSEINACTIVE INGREDIENTC151H8M554GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673GENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGENTLE LAXATIVE (BISACODYL) TABLET [WALGREEN CO.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [WALGREEN COMPANY]24Current NDC, Legacy NDC, 9 package rows20240531_8a419066-f22d-42e6-a855-b1c36fbb22cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN8a419066-f22d-42e6-a855-b1c36fbb22cf25
308753bisacodyl 5 MG Delayed Release Oral TabletSCD8a419066-f22d-42e6-a855-b1c36fbb22cf25
308753bisacodyl 5 MG Enteric Coated Oral TabletSY8a419066-f22d-42e6-a855-b1c36fbb22cf25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0327-03003630327031 BLISTER PACK in 1 CARTON (0363-0327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent
0363-0327-0600363032706200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-0327-06) 2002-03-250000-00-00NoNoCurrent
0363-0327-12003630327124 BLISTER PACK in 1 CARTON (0363-0327-12) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2002-03-250000-00-00NoNoCurrent
0363-0327-36003630327361 BLISTER PACK in 1 CARTON (0363-0327-36) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-252027-02-28NoNoHistorical
0363-0327-56003630327561 BLISTER PACK in 1 CARTON (0363-0327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-250000-00-00NoNoCurrent