FDA.reportPublic FDA data

Dulcolax

Manufacturer
Physicians Total Care, Inc.
Effective date
2011-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:01

Label at a glance#

ProductDulcolax
Active ingredientbisacodyl
Label structure7 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

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 years of age 1/2 suppository in a single daily dose children under 2 years of age ask a doctor

Storage and handling

do not store above 30°C (86°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)Purpose
Bisacodyl USP 10 mg .................................... Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over1 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 years of age1/2 suppository in a single daily dose
children under 2 years of ageask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not store above 30°C (86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax (bisacodyl USP) Laxative Suppositories

10 mg

NDC 54868-3155-1

image of package label
image of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN1
209601Dulcolax 10 MG Rectal SuppositoryPSN1
209601bisacodyl 10 MG Rectal Suppository [Dulcolax]SBD1
198509bisacodyl 10 MG Rectal SuppositorySCD1
209601Dulcolax 10 MG Rectal SuppositorySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BISACODYL Pharmacologic Class Indexing1Indexing - Pharmacologic Class20101101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-3155-12019-09-24C16284748780-19350213a-4970-c013-e053-90daa90a1393Dulcolax® Suppository

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-3155-1Dulcolax4 in 1 BLISTER PACKSUPPOSITORY41
54868-3155-1Dulcolax4 in 1 CARTONSUPPOSITORY41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-3155DULCOLAX (BISACODYL) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]12 package rows20111107_1bf775a9-bd9e-41a6-acef-9a3795fbf25c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-3155-1EA - Each54868-3155445d6b4a-4824-4233-b0a5-d74a51671f7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bisacodylACTIVE INGREDIENT10X0709Y6I1
bisacodylACTIVE MOIETY10X0709Y6I1
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OM1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54868-315554868-3155-1
0597-0052

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
bisacodyl10X0709Y6IACTIB
HYDROGENATED COCONUT OILJY81OXM1OMIACT
HYDROGENATED PALM KERNEL OILFM8D1RE2VPIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROGENATED COCONUT OILHYDROGENATED COCONUT OILJY81OXM1OMSUPPOSITORY / RECTALNAExact identifier — unii candidate

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
5264120b-3fa4-42c6-a517-1d1abc71421a1bf775a9-bd9e-41a6-acef-9a3795fbf25c2011-02-01WarningsExact identifier
spl id: 5264120b-3fa4-42c6-a517-1d1abc71421a
spl set id: 1bf775a9-bd9e-41a6-acef-9a3795fbf25c

Reported adverse events (FAERS/openFDA)#

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