FDA.reportPublic FDA data

Candida albicans

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:23:10

Label at a glance#

ProductCandida albicans
Active ingredientCANDIDA ALBICANS
Label structure18 sections

Dosage and administration

5 pellets 3 times a day until symptoms are relieved.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Candida albicans HPUS
8X, 12X, 6C, 9C, 12C, 15C, 30C, 200CK, 1M, 10M

Use

INDICATIONS & USAGE SECTION

For Relief Of Symptoms Of Yeast Infection*

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 3 days or worsen.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

5 pellets 3 times a day until symptoms are relieved.

Other information

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
contains approx. 80 pellets

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose, sucrose

Questions, Comments?

OTC - QUESTIONS SECTION

1-800-BOIRON-1
Newtown Square, PA 19073-3267
info@boironusa.com

*

SPL UNCLASSIFIED SECTION

These "Uses" have not been evaluated by the FDA.

Principle Display Panel - Candida albicans HPUS 8X

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 8XPrinciple Display Panel - Candida albicans HPUS 8X

Principle Display Panel - Candida albicans HPUS 12X

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 12XPrinciple Display Panel - Candida albicans HPUS 12X

Principle Display Panel - Candida albicans HPUS 6C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 6CPrinciple Display Panel - Candida albicans HPUS 6C

Principle Display Panel - Candida albicans HPUS 9C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 9CPrinciple Display Panel - Candida albicans HPUS 9C

Principle Display Panel - Candida albicans HPUS 12C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 12CPrinciple Display Panel - Candida albicans HPUS 12C

Principle Display Panel - Candida albicans HPUS 15C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 15CPrinciple Display Panel - Candida albicans HPUS 15C

Principle Display Panel - Candida albicans HPUS 30C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 30CPrinciple Display Panel - Candida albicans HPUS 30C

Principle Display Panel - Candida albicans HPUS 200CK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 200CKPrinciple Display Panel - Candida albicans HPUS 200CK

Principle Display Panel - Candida albicans HPUS 1M

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 1MPrinciple Display Panel - Candida albicans HPUS 1M

Principle Display Panel - Candida albicans HPUS 10M

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel - Candida albicans HPUS 10MPrinciple Display Panel - Candida albicans HPUS 10M

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1133-412023-11-09C16284748780-1f386c64a-1411-0266-e053-dadaa90a7c1aCandida albicans
0220-1133-412023-01-30C16284748780-1f386c64a-1411-0266-e053-dadaa90a7c1aCandida albicans

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1133-41Candida albicans80 in 1 TUBEPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1133CANDIDA ALBICANS PELLET [LABORATOIRES BOIRON]4Current NDC, Legacy NDC, 1 package rows20231110_61891db0-7c51-11e6-83bf-424c58303031.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-11330220-1133-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT
CANDIDA ALBICANS4D7G21HDBCACTIB

Source Document#

Source XML · Source PDF

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
Candida albicansCANDIDA ALBICANSLaboratoires Boiron61891db0-7c51-11e6-83bf-424c583030312023-11-09WarningsExact identifier
ndc (package): 0220-1133-41
ndc (product): 0220-1133
ndc11 (package): 00220113341
spl id: 09bea96e-844b-35e1-e063-6394a90a5750
spl set id: 61891db0-7c51-11e6-83bf-424c58303031

Reported adverse events (FAERS/openFDA)#

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