Home NDC 49483-003 STIMULANT LAXATIVE
Product NDC 49483-003
11-digit product format 494830003
Labeler code 49483
Product ID 49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6
Type HUMAN OTC DRUG
Nonproprietary name BISACODYL
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-04-01
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 STIMULANT LAXATIVE
Listing expiration 2026-12-31 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 49483-003-00 STIMULANT LAXATIVE 100000 in 1 CARTON TABLET, DELAYED RELEASE 100000 7 49483-003-01 STIMULANT LAXATIVE 100 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 100 7 49483-003-10 STIMULANT LAXATIVE 1000 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 1000 7 49483-003-52 STIMULANT LAXATIVE 25 in 1 BLISTER PACK TABLET, DELAYED RELEASE 25 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 BISACODYL ACTIVE MOIETY 10X0709Y6I STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 ACACIA INACTIVE INGREDIENT 5C5403N26O STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 CALCIUM SULFATE ANHYDROUS INACTIVE INGREDIENT E934B3V59H STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 POLYVINYL ACETATE PHTHALATE INACTIVE INGREDIENT 58QVG85GW3 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-003 STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20191004_e0a9f8d9-660b-431c-8043-6d8ec81f98e5.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 Marketing start Marketing end Sample Exclude flag Status 49483-003-00 49483000300 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00) 2018-12-07 0000-00-00 No No Current 49483-003-01 49483000301 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01) 2018-12-07 0000-00-00 No No Current 49483-003-10 49483000310 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10) 2018-12-07 0000-00-00 No No Current 49483-003-52 49483000352 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52) 2018-12-07 0000-00-00 No No Current