FDA.reportPublic FDA data

Fem Flora Defense

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2023-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:03

Label at a glance#

ProductFem Flora Defense
Active ingredientBAPTISIA TINCTORIA ROOT, SODIUM BORATE, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS BARK, ECHINACEA ANGUSTIFOLIA WHOLE, NITRIC ACID, PULSATILLA PRATENSIS WHOLE, RANCID BEEF, SEPIA OFFICINALIS JUICE, SULFURIC ACID, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

Adults and children over 12: Spray twice under the tongue 3 times per day. Children 12 and under: Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray) 8.33% of Baptisia Tinctoria 3X, Borax 30C, Candida Albicans 12X, Candida Parapsilosis 8C, Cinchona Officinalis 30C, Echinacea (Angustifolia) 3X, Nitricum Acidum 30C, Pulsatilla (Pratensis) 30C, Pyrogenium 200C, Sepia 30C, Sulphuricum Acidum 30C, Thuja Occidentalis 30C.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms of Candida infections: vaginal discharge, vaginal discomfort, abdominal distention, bloating.**

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

WARNINGS:

WARNINGS SECTION

If symptoms persist for more than 7 days, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: Spray twice under the tongue 3 times per day.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms of Candida infections: vaginal discharge, vaginal discomfort, abdominal distention, bloating.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY LIDDELL LABORATORIES, INC.

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL

LABORATORIES

21Can

Fem Flora Defense

HOMEOPATHIC

1.0 FL OZ. (30 ml)

Fem Flora DefenseFem Flora Defense

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0274-12023-08-17C16284748780-1f386c649-f9da-0266-e053-dadaa90a7c1aDRUG FACTS:
50845-0274-12023-01-30C16284748780-1f386c649-f9da-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0274-1Fem Flora Defense30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0274FEM FLORA DEFENSE (BAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALIS) SPRAY [LIDDELL LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20230818_8015e1cb-9ebd-4b3e-af57-92f2754fb790.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-027450845-0274-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
SODIUM BORATE91MBZ8H3QOACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CANDIDA PARAPSILOSIS0KZ676D44NACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
NITRIC ACID411VRN1TV4ACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
RANCID BEEF29SUH5R3HUACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFURIC ACIDO40UQP6WCFACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Fem Flora DefenseBAPTISIA TINCTORIA, BORAX, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CINCHONA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), NITRICUM ACIDUM, PULSATILLA (PRATENSIS), PYROGENIUM, SEPIA, SULPHURICUM ACIDUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.8015e1cb-9ebd-4b3e-af57-92f2754fb7902023-08-17WarningsExact identifier
ndc (package): 50845-0274-1
ndc (product): 50845-0274
ndc11 (package): 50845027401
spl id: 6a28ccf7-80a2-4db1-a1aa-ec417335b8ae
spl set id: 8015e1cb-9ebd-4b3e-af57-92f2754fb790

Reported adverse events (FAERS/openFDA)#

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