FDA.reportPublic FDA data

stimulant laxative enteric coated

Product NDC
71335-1531
11-digit product format
713351531
Labeler code
71335
Product ID
71335-1531_28debe6e-1735-4f92-a4f2-96d6b3e690bf
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
stimulant laxative enteric coated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1531-0stimulant laxative enteric coated25 in 1 BOTTLETABLET253
71335-1531-1stimulant laxative enteric coated30 in 1 BOTTLETABLET303
71335-1531-2stimulant laxative enteric coated2 in 1 BOTTLETABLET23
71335-1531-3stimulant laxative enteric coated3 in 1 BOTTLETABLET33
71335-1531-4stimulant laxative enteric coated4 in 1 BOTTLETABLET43
71335-1531-5stimulant laxative enteric coated10 in 1 BOTTLETABLET103
71335-1531-6stimulant laxative enteric coated90 in 1 BOTTLETABLET903
71335-1531-7stimulant laxative enteric coated8 in 1 BOTTLETABLET83
71335-1531-8stimulant laxative enteric coated100 in 1 BOTTLETABLET1003
71335-1531-9stimulant laxative enteric coated20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1531STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240120_06940a9d-02bb-4b8e-b1cf-d69d94a30b67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN06940a9d-02bb-4b8e-b1cf-d69d94a30b673
308753bisacodyl 5 MG Delayed Release Oral TabletSCD06940a9d-02bb-4b8e-b1cf-d69d94a30b673
308753bisacodyl 5 MG Enteric Coated Oral TabletSY06940a9d-02bb-4b8e-b1cf-d69d94a30b673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1531-07133515310025 TABLET in 1 BOTTLE (71335-1531-0) 25 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-17133515310130 TABLET in 1 BOTTLE (71335-1531-1) 30 tablet2020-05-140000-00-00NoNoCurrent
71335-1531-2713351531022 TABLET in 1 BOTTLE (71335-1531-2) 2 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-3713351531033 TABLET in 1 BOTTLE (71335-1531-3) 3 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-4713351531044 TABLET in 1 BOTTLE (71335-1531-4) 4 tablet2020-03-090000-00-00NoNoCurrent
71335-1531-57133515310510 TABLET in 1 BOTTLE (71335-1531-5) 10 tablet2020-06-160000-00-00NoNoCurrent
71335-1531-67133515310690 TABLET in 1 BOTTLE (71335-1531-6) 90 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-7713351531078 TABLET in 1 BOTTLE (71335-1531-7) 8 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-871335153108100 TABLET in 1 BOTTLE (71335-1531-8) 100 tablet2022-03-100000-00-00NoNoCurrent
71335-1531-97133515310920 TABLET in 1 BOTTLE (71335-1531-9) 20 tablet2022-03-100000-00-00NoNoCurrent