FDA.reportPublic FDA data

Gentle Laxative

Product NDC
41163-607
11-digit product format
411630607
Labeler code
41163
Product ID
41163-607_9ccbe2e0-b479-40f3-8e82-2b828be00cc5
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-01
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 Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
41163-607-52Gentle Laxative5 in 1 CARTONTABLET, DELAYED RELEASE516
41163-607-52Gentle Laxative18 in 1 BLISTER PACKTABLET, DELAYED RELEASE1816
41163-607-56Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2516
41163-607-56Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-607-52EA - Each41163-607ddf6782c-2803-4c53-8fcb-8e4feaea1b1512017-03-06
41163-607-56EA - Each41163-607d8500363-da4a-4760-a5b8-911c5b9afe8c12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
BISACODYLACTIVE MOIETY10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-607GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]15Current NDC, Legacy NDC, 4 package rows20240724_1daeccb6-b8ab-43dc-a8fd-07ffc1fc1138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN1daeccb6-b8ab-43dc-a8fd-07ffc1fc113816
308753bisacodyl 5 MG Delayed Release Oral TabletSCD1daeccb6-b8ab-43dc-a8fd-07ffc1fc113816
308753bisacodyl 5 MG Enteric Coated Oral TabletSY1daeccb6-b8ab-43dc-a8fd-07ffc1fc113816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-607-52411630607525 BLISTER PACK in 1 CARTON (41163-607-52) / 18 TABLET, DELAYED RELEASE in 1 BLISTER PACK5 blister pack2013-04-010000-00-00NoNoCurrent
41163-607-56411630607561 BLISTER PACK in 1 CARTON (41163-607-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2013-04-010000-00-00NoNoCurrent