FDA.reportPublic FDA data

Dulcolax

Product NDC
0597-0012
11-digit product format
005970012
Labeler code
0597
Product ID
0597-0012_7e3d2ba1-1ea6-62e3-d82d-a0f19a906bb3
Type
HUMAN OTC DRUG
Nonproprietary name
bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2001-10-01
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN2913bcab-0cef-4796-9726-5906f4ec63f81
308753bisacodyl 5 MG Delayed Release Oral TabletPSNeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613Dulcolax 5 MG Delayed Release Oral TabletPSN2913bcab-0cef-4796-9726-5906f4ec63f81
209613Dulcolax 5 MG Delayed Release Oral TabletPSNeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBD2913bcab-0cef-4796-9726-5906f4ec63f81
209613bisacodyl 5 MG Delayed Release Oral Tablet [Dulcolax]SBDeac116c1-d109-4c01-8cd4-ba27ddd2ce401
308753bisacodyl 5 MG Delayed Release Oral TabletSCD2913bcab-0cef-4796-9726-5906f4ec63f81
308753bisacodyl 5 MG Delayed Release Oral TabletSCDeac116c1-d109-4c01-8cd4-ba27ddd2ce401
308753bisacodyl 5 MG Enteric Coated Oral TabletSY2913bcab-0cef-4796-9726-5906f4ec63f81
308753bisacodyl 5 MG Enteric Coated Oral TabletSYeac116c1-d109-4c01-8cd4-ba27ddd2ce401
209613Dulcolax 5 MG Delayed Release Oral TabletSY2913bcab-0cef-4796-9726-5906f4ec63f81
209613Dulcolax 5 MG Delayed Release Oral TabletSYeac116c1-d109-4c01-8cd4-ba27ddd2ce401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0012-00005970012004 BLISTER PACK in 1 CARTON (0597-0012-00) > 25 TABLET, COATED in 1 BLISTER PACK4 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-11005970012111 BLISTER PACK in 1 CARTON (0597-0012-11) > 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-26005970012261 BLISTER PACK in 1 CARTON (0597-0012-26) > 25 TABLET, COATED in 1 BLISTER PACK1 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-37005970012372 BLISTER PACK in 1 CARTON (0597-0012-37) > 15 TABLET, COATED in 1 BLISTER PACK2 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-38005970012381 BLISTER PACK in 1 CARTON (0597-0012-38) > 8 TABLET, COATED in 1 BLISTER PACK1 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-50005970012502 BLISTER PACK in 1 CARTON (0597-0012-50) > 25 TABLET, COATED in 1 BLISTER PACK2 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-58005970012586 BLISTER PACK in 1 CARTON (0597-0012-58) > 25 TABLET, COATED in 1 BLISTER PACK6 blister pack2001-10-010000-00-00NoNoCurrent
0597-0012-59005970012598 BLISTER PACK in 1 CARTON (0597-0012-59) > 25 TABLET, COATED in 1 BLISTER PACK8 blister pack2001-10-010000-00-00NoNoCurrent