FDA.reportPublic FDA data

Proctozone-B

Product NDC
57237-337
11-digit product format
572370337
Labeler code
57237
Product ID
57237-337_ad7d1357-40a1-47d3-bb30-77aaf1547659
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Rising Pharma Holdings, Inc.
Application
M007.60
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
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
Proctozone-B
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-337-03Proctozone-B6 in 1 CARTONSUPPOSITORY62
57237-337-04Proctozone-B4 in 1 BLISTER PACKSUPPOSITORY42
57237-337-21Proctozone-B3 in 1 CARTONSUPPOSITORY32
57237-337-51Proctozone-B5 in 1 BLISTER PACKSUPPOSITORY52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-337-03EA - Each57237-33768a4090e-9719-4079-bb1d-ca2bd4cdde6012025-08-11
57237-337-04EA - Each57237-33702ae42a8-283d-4e63-a6e0-ce3ab92bf58912025-10-14
57237-337-21EA - Each57237-3376f774f0f-ba01-489f-9d72-aa3e78da545c12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-337PROCTOZONE-B (BISACODYL) SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]2Current NDC, 4 package rows20241202_c53ed934-3846-4dc8-b97b-c84171c21ae1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNc53ed934-3846-4dc8-b97b-c84171c21ae12
198509bisacodyl 10 MG Rectal SuppositorySCDc53ed934-3846-4dc8-b97b-c84171c21ae12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-337-03572370337036 BLISTER PACK in 1 CARTON (57237-337-03) / 5 SUPPOSITORY in 1 BLISTER PACK (57237-337-51) 6 blister pack2025-02-01NoNoCurrent
57237-337-04572370337044 in 1 BLISTER PACKHistorical
57237-337-21572370337213 BLISTER PACK in 1 CARTON (57237-337-21) / 4 SUPPOSITORY in 1 BLISTER PACK (57237-337-04) 3 blister pack2024-12-01NoNoCurrent
57237-337-51572370337515 in 1 BLISTER PACKHistorical