Home NDC 41163-607 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 Ingredient Strength BISACODYL 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 10X0709Y6I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-607-52 Gentle Laxative 5 in 1 CARTON TABLET, DELAYED RELEASE 5 16 41163-607-52 Gentle Laxative 18 in 1 BLISTER PACK TABLET, DELAYED RELEASE 18 16 41163-607-56 Gentle Laxative 25 in 1 BLISTER PACK TABLET, DELAYED RELEASE 25 16 41163-607-56 Gentle Laxative 1 in 1 CARTON TABLET, DELAYED RELEASE 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 BISACODYL ACTIVE MOIETY 10X0709Y6I GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [SUPERVALU INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-607 GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI] 15 Current NDC, Legacy NDC, 4 package rows 20240724_1daeccb6-b8ab-43dc-a8fd-07ffc1fc1138.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41163-607-52 41163060752 5 BLISTER PACK in 1 CARTON (41163-607-52) / 18 TABLET, DELAYED RELEASE in 1 BLISTER PACK 5 blister pack 2013-04-01 0000-00-00 No No Current 41163-607-56 41163060756 1 BLISTER PACK in 1 CARTON (41163-607-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK 1 blister pack 2013-04-01 0000-00-00 No No Current