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
2027-12-31

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
8a419066-f22d-42e6-a855-b1c36fbb22cfAvailable on FDA.report

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

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle LaxativeBISACODYLWalgreen Company8a419066-f22d-42e6-a855-b1c36fbb22cf2026-06-15WarningsExact identifier
ndc (product): 0363-0327

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