FDA.reportPublic FDA data

Fenbendazole

Manufacturer
Spectrum Laboratory Products, Inc.
Effective date
2021-01-26
Label type
BULK INGREDIENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:49:52

Label at a glance#

ProductFenbendazole
Active ingredientFENBENDAZOLE
Label structure1 sections

Label contents#

Full prescribing information#

Fenbendazole

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FenbendazoleFenbendazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49452-3035-1Fenbendazole5 g in 1 BOTTLE, GLASSPOWDER54
49452-3035-2Fenbendazole25 g in 1 BOTTLE, GLASSPOWDER254
49452-3035-3Fenbendazole100 g in 1 BOTTLE, GLASSPOWDER1004
49452-3035-4Fenbendazole1000 g in 1 BOTTLE, GLASSPOWDER10004
49452-3035-5Fenbendazole25000 g in 1 DRUMPOWDER250004
49452-3035-6Fenbendazole5000 g in 1 PAILPOWDER50004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49452-3035FENBENDAZOLE POWDER [SPECTRUM LABORATORY PRODUCTS, INC.]46 package rows20210128_c4f6cd48-d024-42d1-9932-c5b64be41dd7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49452-3035-1GM - Gram49452-3035ea260a61-2e18-438b-a092-10046049b0d612017-08-11
49452-3035-2GM - Gram49452-3035daff0466-9946-4990-b00d-06a20e07bceb12017-08-11
49452-3035-3GM - Gram49452-30354d5d86b0-f875-4b2a-a68e-456e92449e8f12017-08-11
49452-3035-4GM - Gram49452-3035e91f75a4-e00d-48d8-ad9c-e3dd432d442a12017-08-11
49452-3035-5GM - Gram49452-30356cd2b2be-0e59-4748-b651-cb620e8706fe12017-08-11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49452-303549452-3035-1, 49452-3035-2, 49452-3035-3, 49452-3035-4, 49452-3035-5, 49452-3035-6

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
FENBENDAZOLE621BVT9M36ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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