OneLAX

Product NDC
71399-8460
11-digit product format
713998460
Labeler code
71399
Product ID
71399-8460_42b7c75d-d66d-77f9-e063-6294a90a4e40
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
AKRON PHARMA INC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-13
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
OneLAX
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8460-2OneLAX1 in 1 BLISTER PACKSUPPOSITORY14
71399-8460-2OneLAX12 in 1 BOXSUPPOSITORY124
71399-8460-5OneLAX50 in 1 BOXSUPPOSITORY504
71399-8460-5OneLAX1 in 1 BLISTER PACKSUPPOSITORY14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8460-2EA - Each71399-8460973def14-1a56-4c0d-801c-477693cc4a0312021-12-08
71399-8460-5EA - Each71399-8460102289e2-cc58-4793-9fca-b8c4be2c7e2b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8460ONELAX (BISACODYL) SUPPOSITORY [AKRON PHARMA INC]3Current NDC, Legacy NDC, 4 package rows20240922_be4eeb4d-df29-45dc-94ff-933e52c8b6f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNbe4eeb4d-df29-45dc-94ff-933e52c8b6f64
198509bisacodyl 10 MG Rectal SuppositorySCDbe4eeb4d-df29-45dc-94ff-933e52c8b6f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-8460-27139984600212 BLISTER PACK in 1 BOX (71399-8460-2) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2024-09-130000-00-00NoNoCurrent
71399-8460-57139984600550 BLISTER PACK in 1 BOX (71399-8460-5) / 1 SUPPOSITORY in 1 BLISTER PACK50 blister pack2024-09-130000-00-00NoNoCurrent