Dulcolax

Product NDC
29485-6741
11-digit product format
294856741
Labeler code
29485
Product ID
29485-6741_92448d56-6df2-40f1-9d69-2f42999ae3c0
Type
HUMAN OTC DRUG
Nonproprietary name
bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Mechanical Servants, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct29485-6741IInactivated by FDA2026-10-12
excluded packagepackage29485-674129485-6741-3IInactivated by FDA2026-10-12

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage29485-6741-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage29485-6741-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage29485-6741-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage29485-6741-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage29485-6741-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage29485-6741-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage29485-6741-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage29485-6741-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage29485-6741-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage29485-6741-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage29485-6741-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage29485-6741-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage29485-6741-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage29485-6741-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage29485-6741-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage29485-6741-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage29485-6741-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage29485-6741-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage29485-6741-38dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage29485-6741-3e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage29485-6741-39bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage29485-6741-3110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29485-6741-32019-11-13C16284748780-197449f38-b900-f6ea-e053-dbdaa90aa703Dulcolax ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-6741-3Dulcolax1 in 1 PACKAGETABLET, COATED11
29485-6741-3Dulcolax3 in 1 POUCHTABLET, COATED31

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bisacodylACTIVE INGREDIENT10X0709Y6IDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
bisacodylACTIVE MOIETY10X0709Y6IDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
acaciaINACTIVE INGREDIENT5C5403N26ODULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
cellacefateINACTIVE INGREDIENTF2O5O2OI9FDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
diacetylated monoglyceridesINACTIVE INGREDIENT5Z17386USFDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
dibutyl phthalateINACTIVE INGREDIENT2286E5R2KEDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
kaolinINACTIVE INGREDIENT24H4NWX5CODULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
lactoseINACTIVE INGREDIENTJ2B2A4N98GDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
shellacINACTIVE INGREDIENT46N107B71ODULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1
white waxINACTIVE INGREDIENT7G1J5DA97FDULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-6741DULCOLAX (BISACODYL) TABLET, COATED [MECHANICAL SERVANTS, INC.]1Legacy NDC, 2 package rows20120308_eac116c1-d109-4c01-8cd4-ba27ddd2ce40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613Dulcolax 5 MG Delayed Release Oral TabletPSNeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBDeac116c1-d109-4c01-8cd4-ba27ddd2ce401
308753bisacodyl 5 MG Delayed Release Oral TabletSCDeac116c1-d109-4c01-8cd4-ba27ddd2ce401
308753bisacodyl 5 MG Enteric Coated Oral TabletSYeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613Dulcolax 5 MG Delayed Release Oral TabletSYeac116c1-d109-4c01-8cd4-ba27ddd2ce401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
29485-6741-3294856741031 in 1 PACKAGEHistorical