FDA.reportPublic FDA data

Candida

Manufacturer
Zorex International | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:56

Label at a glance#

ProductCandida
Active ingredientBAPTISIA TINCTORIA WHOLE, ECHINACEA PURPUREA WHOLE, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PULSATILLA VULGARIS WHOLE, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (*HPUS): equal amounts of: Baptisia Tinctoria 4X, Echinacea Purp 4X, GLycyrrhiza Glabra 4X, Astragalus 6X, Candida Alb 10C, 30C, 200C, Borax 30C, Calc Carb 30C, Kreosotum 30C, Lycopodium 30C, Nux Vom 30C, Phosphoricum Ac 30C, Pulsatilla 30C, Sepia 30C, Thuja Occ 30C, Nat Phos 30C, Nitricum Ac 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves symptoms associated with vaginal yeast.**

OTC - PURPOSE SECTION

USES: Temporarily relieves symptoms associated with vaginal yeast.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Zorex International LTD. / Lowell, MI 49331 / 800-679-3027

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:81825-0004-1

Candida

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0004-1Candida30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81825-0004CANDIDA (BAPTISIA TINCTORIA, ECHINACEA PURP, GLYCYRRHIZA GLABRA, ASTRAGALUS, CANDIDA ALB, BORAX, CALC CARB, KREOSOTUM, LYCOPODIUM, NUX VOM, PHOSPHORICUM AC, PULSATILLA, SEPIA, THUJA OCC, NAT PHOS, NITRICUM AC) LIQUID [ZOREX INTERNATIONAL]1Current NDC, 1 package rows20230420_c6595326-6d04-499e-9eb7-0a4cd2ba48fd.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81825-000481825-0004-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA WHOLE5K1UO2888YACTIB
ECHINACEA PURPUREA WHOLEQI7G114Y98ACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ASTRAGALUS NUTTALLII LEAFNC1P15G4KZACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
SODIUM BORATE91MBZ8H3QOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
NITRIC ACID411VRN1TV4ACTIB
ALCOHOL3K9958V90MIACT
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
CandidaBAPTISIA TINCTORIA, ECHINACEA PURP, GLYCYRRHIZA GLABRA, ASTRAGALUS, CANDIDA ALB, BORAX, CALC CARB, KREOSOTUM, LYCOPODIUM, NUX VOM, PHOSPHORICUM AC, PULSATILLA, SEPIA, THUJA OCC, NAT PHOS, NITRICUM ACZorex Internationalc6595326-6d04-499e-9eb7-0a4cd2ba48fd2018-12-21WarningsExact identifier
ndc (package): 81825-0004-1
ndc (product): 81825-0004
ndc11 (package): 81825000401
spl id: 32b5e01c-67ef-4251-b6a4-b7e007fafc83
spl set id: c6595326-6d04-499e-9eb7-0a4cd2ba48fd

Reported adverse events (FAERS/openFDA)#

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