FDA.reportPublic FDA data

Laxative

Product NDC
55301-676
11-digit product format
553010676
Labeler code
55301
Product ID
55301-676_31e54f33-b48c-4e1a-a673-82c38a28a33f
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-09-16
Marketing end
0000-00-00
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
2023-12-31
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 productproduct55301-676DDiscontinued by firm2026-10-20
excluded packagepackage55301-67655301-676-11DDiscontinued by firm2026-10-20

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct55301-676DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55301-67655301-676-11DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ILAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
BISACODYLACTIVE MOIETY10X0709Y6ILAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAXATIVE (BISACODYL) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-676LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [ARMY AND AIR FORCE EXCHANGE SERVICE]14Legacy NDC20240625_65c2008d-fee6-41af-b788-737f393284cc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-676-11553010676114 BLISTER PACK in 1 CARTON (55301-676-11) > 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2015-09-160000-00-00NoNoCurrent