FDA.reportPublic FDA data

Bromhexine Hydrochloride

Manufacturer
Bidachem S.p.a.
Effective date
2022-12-20
Label type
BULK INGREDIENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:37

Label at a glance#

ProductBromhexine Hydrochloride
Active ingredientBROMHEXINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

bromhexine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bromhexine1bromhexine1bromhexine2bromhexine2bromhexine3bromhexine3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51869-0009-9Bromhexine Hydrochloride60000 g in 1 DRUMPOWDER600002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51869-0009BROMHEXINE HYDROCHLORIDE POWDER [BIDACHEM S.P.A.]21 package rows20221221_34657a3c-8c4d-6e5d-e054-00144ff88e88.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
51869-000951869-0009-9

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
BROMHEXINE HYDROCHLORIDEYC2ZOM3Z8VACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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