FDA.reportPublic FDA data

Phenylbutazone

Manufacturer
Spectrum Laboratory Products, Inc. | Spectrum Laboratory Products, Inc
Effective date
2021-11-29
Label type
BULK INGREDIENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:14

Label at a glance#

ProductPhenylbutazone
Active ingredientPHENYLBUTAZONE
Label structure1 sections

Label contents#

Full prescribing information#

Phenylbutazone, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PhenylbutazonePhenylbutazone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49452-5286-1Phenylbutazone25 g in 1 BOTTLE, GLASSPOWDER253
49452-5286-2Phenylbutazone100 g in 1 BOTTLE, GLASSPOWDER1003
49452-5286-3Phenylbutazone500 g in 1 BOTTLE, GLASSPOWDER5003
49452-5286-4Phenylbutazone1000 g in 1 PAILPOWDER10003
49452-5286-5Phenylbutazone5000 g in 1 PAILPOWDER50003
49452-5286-6Phenylbutazone25000 g in 1 DRUMPOWDER250003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49452-5286PHENYLBUTAZONE POWDER [SPECTRUM LABORATORY PRODUCTS, INC.]36 package rows20211201_af9d937d-f346-cac4-e053-2a95a90a7154.zip

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
49452-528649452-5286-1, 49452-5286-2, 49452-5286-3, 49452-5286-4, 49452-5286-5, 49452-5286-6

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
PHENYLBUTAZONEGN5P7K3T8SACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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