FDA.reportPublic FDA data

Womens Gentle Laxative

Product NDC
46122-429
11-digit product format
461220429
Labeler code
46122
Product ID
46122-429_26b479d2-0488-4fb9-982f-a6a4ec0ff356
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-01
Marketing end
2028-02-29
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 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
307757cc-22d5-4401-9e71-e8d2202a538cAvailable 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
46122-429-63Womens Gentle Laxative1 in 1 CARTONTABLET, DELAYED RELEASE111
46122-429-63Womens Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-429-63EA - Each46122-429bc8bf11f-28ce-41f1-88e1-674a47321f3112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-429WOMENS GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]10Current NDC, Legacy NDC, 2 package rows20240727_307757cc-22d5-4401-9e71-e8d2202a538c.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
Womens Gentle LaxativeBISACODYLAmerisource Bergen307757cc-22d5-4401-9e71-e8d2202a538c2025-07-22WarningsExact identifier
ndc (product): 46122-429

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN307757cc-22d5-4401-9e71-e8d2202a538c11
308753bisacodyl 5 MG Delayed Release Oral TabletSCD307757cc-22d5-4401-9e71-e8d2202a538c11
308753bisacodyl 5 MG Enteric Coated Oral TabletSY307757cc-22d5-4401-9e71-e8d2202a538c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-429-63461220429631 BLISTER PACK in 1 CARTON (46122-429-63) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2013-04-012028-02-29NoNoCurrent