Home NDC 55319-327 Laxative
Product NDC 55319-327
11-digit product format 553190327
Labeler code 55319
Product ID 55319-327_5913d42b-489c-408d-9fb2-1e1a0e1837e5
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Family Dollar Services 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 · 12 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…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 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 55319-327-15 Laxative 25 in 1 BLISTER PACK TABLET, DELAYED RELEASE 25 11 55319-327-15 Laxative 2 in 1 CARTON TABLET, DELAYED RELEASE 2 11 55319-327-56 Laxative 25 in 1 BLISTER PACK TABLET, DELAYED RELEASE 25 11 55319-327-56 Laxative 1 in 1 CARTON TABLET, DELAYED RELEASE 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-327 LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [FAMILY DOLLAR SERVICES INC] 10 Current NDC, Legacy NDC, 4 package rows 20250130_af976b4a-f444-49f4-9843-99638ed07d36.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 55319-327-15 55319032715 2 BLISTER PACK in 1 CARTON (55319-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2 blister pack 2002-03-25 0000-00-00 No No Current 55319-327-56 55319032756 1 BLISTER PACK in 1 CARTON (55319-327-56) > 25 TABLET, SUGAR COATED in 1 BLISTER PACK 1 blister pack 2002-03-25 0000-00-00 No No Current