FDA.reportPublic FDA data

Metronidazole Benzoate

Manufacturer
H3 Medical Inc.
Effective date
2019-05-01
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:16

Label at a glance#

ProductMetronidazole Benzoate
Active ingredientMETRONIDAZOLE BENZOATE
Label structure1 sections

Label contents#

Full prescribing information#

Bulk Ingredient. Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Metronidazole BenzoateMetronidazole Benzoate

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63732-2047-9Metronidazole Benzoate25000 g in 1 DRUMPOWDER250001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63732-2047METRONIDAZOLE BENZOATE POWDER [H3 MEDICAL INC.]11 package rows20190502_67ef25a9-35ff-421e-a823-b0fb378e1dcd.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63732-204763732-2047-9

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
METRONIDAZOLE BENZOATEA355C835XCACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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