ZELCOM

Manufacturer
OASIS TRADING
Effective date
2018-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:20

Label at a glance#

ProductZELCOM
Active ingredientFLUBENDAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Flubendazol

OTC - PURPOSE SECTION

Flubendazol is an anthelmintic (an-thel-MIN-tik) or anti-worm medication. It prevents newly hatched insect larvae (worms) from growing or multiplying in your body

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

■ adult and children 2 years of age and older: 1 tablet

■ children under 1 years of age: ask a doctor

WARNINGS SECTION

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

cellulose, corn starch, magnesium stearate, sodium starch

DOSAGE & ADMINISTRATION SECTION

For oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72689-0009-12020-01-31C16284748780-19d75b9d0-386b-f424-e053-dadaa90a57ce7b27090d-7c51-df82-e053-2a91aa0ad708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0009-1ZELCOM1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0009ZELCOM (FLUBENDAZOL) TABLET [OASIS TRADING]1Legacy NDC, 1 package rows20181121_7b27090d-7c51-df82-e053-2a91aa0ad708.zip

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
72689-000972689-0009-1

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
MAGNESIUM STEARATE70097M6I30IACT
FLUBENDAZOLER8M46911LRACTIB

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
7b27090d-7c52-df82-e053-2a91aa0ad7087b27090d-7c51-df82-e053-2a91aa0ad7082018-11-21WarningsExact identifier
spl id: 7b27090d-7c52-df82-e053-2a91aa0ad708
spl set id: 7b27090d-7c51-df82-e053-2a91aa0ad708

Reported adverse events (FAERS/openFDA)#

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