FDA.reportPublic FDA data

Antibacterial

Manufacturer
Collective Science Integration | P&P International
Effective date
2021-02-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:19

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DosageDosage

INACTIVE INGREDIENT SECTION

InactiveInactive

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

OTC - ACTIVE INGREDIENT SECTION

ActivesActives

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from childrenKeep away from children

OTC - PURPOSE SECTION

PurposePurpose

WARNINGS AND PRECAUTIONS SECTION

WarningsWarnings

WARNINGS SECTION

WarningWarning

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90055-210-082022-07-29C16284748780-1e4f33bdf-acea-d8a0-e053-dadaa90a6e4eb142d698-3695-b9b4-e053-2a95a90a32f4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90055-210-08Antibacterial240 mg in 1 BOTTLESOLUTION2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90055-210ANTIBACTERIAL (ANTI BACTERIAL) SOLUTION [COLLECTIVE SCIENCE INTEGRATION]1Legacy NDC, 1 package rows20210220_b142d698-3695-b9b4-e053-2a95a90a32f4.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90055-21090055-210-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
LAVENDER OILZBP1YXW0H8IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCOL STEARATE0324G66D0EIACT
WATER059QF0KO0RIACT

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
b142d698-3696-b9b4-e053-2a95a90a32f4b142d698-3695-b9b4-e053-2a95a90a32f42021-02-18WarningsExact identifier
spl id: b142d698-3696-b9b4-e053-2a95a90a32f4
spl set id: b142d698-3695-b9b4-e053-2a95a90a32f4

Reported adverse events (FAERS/openFDA)#

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