FDA.reportPublic FDA data

Bisacodyl

Manufacturer
Rising Pharma Holdings, Inc. | Bliss GVS Pharma Limited
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:01:06

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure17 sections

Storage and handling

Other information store at 20-25°C (68-77°F) if suppository softens prior to use, may be placed in refrigerator for short time

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

OTC - PURPOSE SECTION

Purpose

Stimulant Laxative

INDICATIONS & USAGE SECTION

Use

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 15 minutes to 1 hour

WARNINGS SECTION

Warnings

For rectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

OTC - WHEN USING SECTION

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you need to use a laxative product for longer than one week
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children

12 years of age and over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes

children 6 to under 12 years1/2 suppository in a single daily dose
children under 6 yearsDo not use

STORAGE AND HANDLING SECTION

Other information

  • store at 20-25°C (68-77°F)
  • if suppository softens prior to use, may be placed in refrigerator for short time

INACTIVE INGREDIENT SECTION

Inactive ingredient hard fat

OTC - QUESTIONS SECTION

Questions or Comments? Call 1-844-474-7464

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

CODE NO.: MH/DRUGS/25-KD/724

Issued: 08/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57237-327-21 (3 blisters of 4 suppositories)

Bisacodyl USP Suppositories 10 mg

Stimulant Laxative

Gentle, Predictable, Fast Relief

DO NOT SWALLOW

Bisc-supp-01Bisc-supp-01

NDC 57237-327-04 (4 suppositories in 1 blister pack)

Front Foil

Bisc-supp-02Bisc-supp-02

Back Foil

Bisc-supp-03Bisc-supp-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN3
198509bisacodyl 10 MG Rectal SuppositorySCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

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
57237-327-03Bisacodyl6 in 1 CARTONSUPPOSITORY63
57237-327-04Bisacodyl4 in 1 BLISTER PACKSUPPOSITORY43
57237-327-21Bisacodyl3 in 1 CARTONSUPPOSITORY33
57237-327-51Bisacodyl5 in 1 BLISTER PACKSUPPOSITORY53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-327BISACODYL SUPPOSITORY [RISING PHARMA HOLDINGS, INC.]3Current NDC, 4 package rows20250519_03429da4-1ce9-4789-bf54-ce1b3215b013.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-327-03EA - Each57237-32726687f9a-1aa2-489f-a83a-51ace49f44d312024-02-14
57237-327-21EA - Each57237-3279be48a32-478d-4f9b-a20d-bea36f4a380112024-02-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-32757237-327-04, 57237-327-21, 57237-327-51, 57237-327-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
FAT, HARD8334LX7S21IACT

Source Document#

Source XML

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
BisacodylBISACODYLRising Pharma Holdings, Inc.03429da4-1ce9-4789-bf54-ce1b3215b0132025-05-13WarningsExact identifier
ndc (package): 57237-327-51
ndc (package): 57237-327-21
ndc (package): 57237-327-03
ndc (package): 57237-327-04
ndc (product): 57237-327
ndc11 (package): 57237032751
ndc11 (package): 57237032721
ndc11 (package): 57237032703
ndc11 (package): 57237032704
spl id: cb24a71e-830c-43ea-9127-446c4b84dc15
spl set id: 03429da4-1ce9-4789-bf54-ce1b3215b013

Reported adverse events (FAERS/openFDA)#

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