FDA.reportPublic FDA data

Womens Gentle Laxative

Product NDC
63868-573
11-digit product format
638680573
Labeler code
63868
Product ID
63868-573_a520623c-946d-45da-a03c-76a10a3ed520
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-17
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Womens Gentle Laxative

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
63868-573-30Womens Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE28
63868-573-30Womens Gentle Laxative15 in 1 BLISTER PACKTABLET, DELAYED RELEASE158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-573-30EA - Each63868-5739430315b-fdb9-483b-b171-1f019c0964cc12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-573WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]7Current NDC, Legacy NDC, 2 package rows20250215_5a6aa2df-bf69-465d-ba62-e660b13f16cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5a6aa2df-bf69-465d-ba62-e660b13f16cd8
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5a6aa2df-bf69-465d-ba62-e660b13f16cd8
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5a6aa2df-bf69-465d-ba62-e660b13f16cd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-573-30638680573302 BLISTER PACK in 1 CARTON (63868-573-30) / 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2020-02-172027-01-31NoNoCurrent