FDA.reportPublic FDA data

LAXATIVE

Product NDC
70795-1010
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

Additional Listing Data#

Finished product
Yes
Brand name base
LAXATIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui198509

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-1010-12025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-1010-1LAXATIVE100 in 1 PACKAGESUPPOSITORY1006
70795-1010-1LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-5LAXATIVE50 in 1 BOXSUPPOSITORY506
70795-1010-5LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-8LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-8LAXATIVE8 in 1 BOXSUPPOSITORY86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-1010-1EA - Each70795-1010feb8228f-67b4-4f76-b795-aaec965ecdda12017-10-13
70795-1010-5EA - Each70795-1010e6ba232c-9924-4530-b835-c091e95aa86512017-10-13
70795-1010-8EA - Each70795-101046df6db7-0319-43ed-97b8-5696578b525412017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70795-1010LAXATIVE (BISACODYL) SUPPOSITORY [GRAXCELL PHARMACEUTICAL, LLC]5Current NDC, Legacy NDC, 6 package rows20211222_5a65d4ab-447f-42bb-b38d-070db523b806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN5a65d4ab-447f-42bb-b38d-070db523b8066
198509bisacodyl 10 MG Rectal SuppositorySCD5a65d4ab-447f-42bb-b38d-070db523b8066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70795-1010-170795101001100 BLISTER PACK in 1 PACKAGE (70795-1010-1) / 1 SUPPOSITORY in 1 BLISTER PACK100 blister pack2017-04-220000-00-00NoNoCurrent
70795-1010-57079510100550 BLISTER PACK in 1 BOX (70795-1010-5) / 1 SUPPOSITORY in 1 BLISTER PACK50 blister pack2017-04-220000-00-00NoNoCurrent
70795-1010-8707951010088 BLISTER PACK in 1 BOX (70795-1010-8) / 1 SUPPOSITORY in 1 BLISTER PACK8 blister pack2017-03-290000-00-00NoNoCurrent