FDA.reportPublic FDA data

Laxative

Product NDC
70677-1086
Requested package NDC
70677-1086-3
11-digit product format
706771086
Labeler code
70677
Product ID
70677-1086_d94253c2-accf-4cdb-9e70-43780c451e15
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c14524f6-1cdf-4212-b6c8-5f2cfc76b4f2Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxativeBISACODYLStrategic Sourcing Services LLCc14524f6-1cdf-4212-b6c8-5f2cfc76b4f22026-06-15WarningsExact identifier
ndc (package): 70677-1086-3
ndc (product): 70677-1086
ndc11 (package): 70677108603

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 formatDescriptionMarketing startSampleExclude flagStatus
70677-1086-370677108603100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70677-1086-3) 2023-04-15NoNoCurrent