FDA.reportPublic FDA data

SYMBIO PARA/ROQUEFORTI DROPS

Manufacturer
Symbiopathic | Biological Health Group Corporation
Effective date
2023-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:21:11

Label at a glance#

ProductSYMBIO PARA/ROQUEFORTI DROPS
Active ingredientPENICILLIUM ROQUEFORTI, CANDIDA PARAPSILOSIS
Label structure12 sections

Dosage and administration

Take 5 – 10 drops orally, three times per day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Candida parapsilosis 4X
Penicillium roqueforti 4X

WARNINGS:

WARNINGS SECTION

Do not use if the tamper evident strip is broken or removed from the base of the cap.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Take 5 – 10 drops orally, three times per day.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Purified water, sodium chloride

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or call a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

This remedy is indicated for symptoms associated with yeast infections and intestinal dysbacteria according to traditional homeopathic practice.*

PURPOSE:

OTC - PURPOSE SECTION

For internal indications according to traditional homeopathic practice.

If pregnant or breast feeding...

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

ASK DOCTOR:

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms worsen or last for more than 7 days.

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

Protect from light and heat.

For professional distribution only.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Para-Roqueforti 4XPara-Roqueforti 4X

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69711-165-112024-07-30C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X
69711-165-112024-01-30C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X
69711-165-112023-05-15C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X
69711-165-112022-01-28C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X
69711-165-112020-03-26C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X
69711-165-112020-01-31C16284748780-19d75b9d0-cf9a-f424-e053-dadaa90a57cePARA-ROQUEFORTI 4X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69711-165-11SYMBIO PARA/ROQUEFORTI DROPS1 in 1 CARTONLIQUID13
69711-165-11SYMBIO PARA/ROQUEFORTI DROPS10 mL in 1 BOTTLELIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69711-165SYMBIO PARA/ROQUEFORTI DROPS (CANDIDA PARAPSILOSIS, PENICILLIUM ROQUEFORTI) LIQUID [SYMBIOPATHIC]3Legacy NDC, 2 package rows20230516_3c56e7f3-731e-0657-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69711-16569711-165-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
PENICILLIUM ROQUEFORTI7ORP6R724LACTIB
CANDIDA PARAPSILOSIS0KZ676D44NACTIB

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
fbbfa61a-cbb6-3104-e053-6394a90a832f3c56e7f3-731e-0657-e054-00144ff8d46c2023-05-15WarningsExact identifier
spl id: fbbfa61a-cbb6-3104-e053-6394a90a832f
spl set id: 3c56e7f3-731e-0657-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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