FDA.reportPublic FDA data

Gentle Laxative

Product NDC
49035-327
11-digit product format
490350327
Labeler code
49035
Product ID
49035-327_26c92954-5092-4b80-8c97-f48e62f306af
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
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
2027-12-31
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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-327-12Gentle Laxative100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10015
49035-327-19Gentle Laxative8 in 1 BLISTER PACKTABLET, DELAYED RELEASE815
49035-327-19Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-327-12EA - Each49035-327bf4b6ce8-d2b0-49ac-a4a6-37142db461f612013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
BISACODYLACTIVE MOIETY10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
ACACIAINACTIVE INGREDIENT5C5403N26OGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
SHELLACINACTIVE INGREDIENT46N107B71OGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
SUCROSEINACTIVE INGREDIENTC151H8M554GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [WAL-MART STORES INC]14Current NDC, Legacy NDC, 3 package rows20250327_ea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e15
308753bisacodyl 5 MG Delayed Release Oral TabletSCDea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e15
308753bisacodyl 5 MG Enteric Coated Oral TabletSYea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-327-1249035032712100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-327-12) 2002-03-250000-00-00NoNoCurrent
49035-327-19490350327191 BLISTER PACK in 1 CARTON (49035-327-19) / 8 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2025-02-18NoNoCurrent