FDA.reportPublic FDA data

Laxative

Product NDC
70677-1086
11-digit product format
706771086
Labeler code
70677
Product ID
70677-1086_4e922653-e74f-4763-b368-9299f7d9e0ab
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Laxative
Listing expiration
2027-12-31

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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1086-1Laxative10 in 1 BLISTER PACKTABLET, DELAYED RELEASE105
70677-1086-1Laxative1 in 1 CARTONTABLET, DELAYED RELEASE15
70677-1086-2Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE255
70677-1086-2Laxative1 in 1 CARTONTABLET, DELAYED RELEASE15
70677-1086-3Laxative100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1086-1EA - Each70677-1086e27a7194-7ce2-4a76-9dad-69f1248062e312023-09-05
70677-1086-2EA - Each70677-10869fb24a44-74e9-44ec-99a3-ef6f8e45a8c512023-09-05
70677-1086-3EA - Each70677-10867a8058ac-8d14-4922-b977-41f99edf910a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1086LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [STRATEGIC SOURCING SERVICES LLC]4Current NDC, 5 package rows20250428_c14524f6-1cdf-4212-b6c8-5f2cfc76b4f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc14524f6-1cdf-4212-b6c8-5f2cfc76b4f25
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc14524f6-1cdf-4212-b6c8-5f2cfc76b4f25
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc14524f6-1cdf-4212-b6c8-5f2cfc76b4f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1086-1706771086011 BLISTER PACK in 1 CARTON (70677-1086-1) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2023-04-15NoNoHistorical
70677-1086-2706771086021 BLISTER PACK in 1 CARTON (70677-1086-2) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2023-04-15NoNoHistorical
70677-1086-370677108603100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70677-1086-3) 2023-04-15NoNoHistorical