Home NDC 49035-327 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 49035-327-12 Gentle Laxative 100 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 100 15 49035-327-19 Gentle Laxative 8 in 1 BLISTER PACK TABLET, DELAYED RELEASE 8 15 49035-327-19 Gentle Laxative 1 in 1 CARTON TABLET, DELAYED RELEASE 1 15
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 [WAL-MART STORES INC] 2 BISACODYL ACTIVE MOIETY 10X0709Y6I GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM GENTLE LAXATIVE (BISACODYL) TABLET, SUGAR COATED [WAL-MART STORES INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-327 GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [WAL-MART STORES INC] 14 Current NDC, Legacy NDC, 3 package rows 20250327_ea6ce0e8-7e0e-4cce-84d5-84094ddf1f0e.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 49035-327-12 49035032712 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49035-327-12) 2002-03-25 0000-00-00 No No Current 49035-327-19 49035032719 1 BLISTER PACK in 1 CARTON (49035-327-19) / 8 TABLET, DELAYED RELEASE in 1 BLISTER PACK 1 blister pack 2025-02-18 No No Current