Home NDC 70795-1010-8 LAXATIVE
Product NDC 70795-1010
Requested package NDC 70795-1010-8
11-digit product format 707951010
Labeler code 70795
Product ID 70795-1010_46d42c6c-5340-c5b9-e063-6394a90a539e
Type HUMAN OTC DRUG
Nonproprietary name BISACODYL
Dosage form SUPPOSITORY
Route RECTAL
Labeler GRAXCELL PHARMACEUTICAL, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-03-29
Substance BISACODYL
Active strength 10 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 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 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LAXATIVE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISACODYL 10 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 198509 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 70795-1010-1 2025-12-26 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-5 2025-12-26 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-8 2025-12-26 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-1 2024-01-30 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-5 2024-01-30 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-8 2024-01-30 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-1 2020-11-16 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-5 2020-11-16 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-8 2020-11-16 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-1 2020-01-31 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-5 2020-01-31 LAXATIVE SUPPOSITORIES, 70795-1010 70795-1010-8 2020-01-31 LAXATIVE SUPPOSITORIES, 70795-1010
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70795-1010-1 LAXATIVE 100 in 1 PACKAGE SUPPOSITORY 100 6 70795-1010-1 LAXATIVE 1 in 1 BLISTER PACK SUPPOSITORY 1 6 70795-1010-5 LAXATIVE 50 in 1 BOX SUPPOSITORY 50 6 70795-1010-5 LAXATIVE 1 in 1 BLISTER PACK SUPPOSITORY 1 6 70795-1010-8 LAXATIVE 1 in 1 BLISTER PACK SUPPOSITORY 1 6 70795-1010-8 LAXATIVE 8 in 1 BOX SUPPOSITORY 8 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70795-1010 LAXATIVE (BISACODYL) SUPPOSITORY [GRAXCELL PHARMACEUTICAL, LLC] 5 Current NDC, Legacy NDC, 6 package rows 20211222_5a65d4ab-447f-42bb-b38d-070db523b806.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 14 of 42 · 833 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 70795-1010-8 70795101008 8 BLISTER PACK in 1 BOX (70795-1010-8) / 1 SUPPOSITORY in 1 BLISTER PACK 8 blister pack 2017-03-29 0000-00-00 No No Current