FDA.reportPublic FDA data

Fivestar

Manufacturer
Midlab Incorporated
Effective date
2018-08-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:52:51

Label at a glance#

ProductFivestar
Active ingredientCHLOROXYLENOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrincipalPrincipal

OTC - ACTIVE INGREDIENT SECTION

ActiveActive

OTC - PURPOSE SECTION

PurposePurpose

INDICATIONS & USAGE SECTION

IndicationsIndications

WARNINGS SECTION

WarningsWarnings

OTC - ASK DOCTOR SECTION

Ask DoctorAsk Doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KOOROCKOOROC

DOSAGE & ADMINISTRATION SECTION

DosageDosage

INACTIVE INGREDIENT SECTION

InactiveInactive

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70542-30570542-305-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM SULFATE0YPR65R21JIACT
GLYCOL STEARATE0324G66D0EIACT
CHLOROXYLENOL0F32U78V2QACTIB
TRIMETHYLENEDIAMINETETRAACETIC ACID3F6OA94EERIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT

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
c5fc7d5e-434b-d523-e053-2995a90a11e346d82fd0-4245-252d-e054-00144ff88e882021-06-30WarningsExact identifier
spl set id: 46d82fd0-4245-252d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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