FDA.reportPublic FDA data

Female Discomforts

Manufacturer
King Bio Inc.
Effective date
2016-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:02

Label at a glance#

ProductFemale Discomforts
Active ingredientAPIS MELLIFERA, ATROPA BELLADONNA, SODIUM BORATE, BRYONIA ALBA ROOT, TRIBASIC CALCIUM PHOSPHATE, LYTTA VESICATORIA, GOLDENSEAL, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, PULSATILLA PRATENSIS, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Apis mellifica, Belladonna, Borax, Bryonia, Calcarea phosphorica, Cantharis, Hydrastis canadensis, Kali bichromicum, Lac caninum, Pulsatilla, Sepia, Thuja occidentalis. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

INDICATIONS & USAGE SECTION

Uses ​for temporary relief of vaginal discomforts associated with yeast overgrowth or irritations: itching, burning, discharges, soreness, dryness, and swelling.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of vaginal discomforts associated with yeast overgrowth or irritations:

  • itching
  • burning
  • discharges
  • soreness
  • dryness
  • swelling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5007-22020-01-31C16284748780-19d75b9d0-99dc-f424-e053-dadaa90a57ceFemale Discomforts™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5007-2Female Discomforts59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5007FEMALE DISCOMFORTS (APIS MELLIFICA, BELLADONNA, BORAX, BRYONIA, CALCAREA PHOSPHORICA, CANTHARIS, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAC CANINUM, PULSATILLA, SEPIA, THUJA OCCIDENTALIS) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160624_32b47a06-72ef-4d73-9faf-d6488ea84ac3.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-500757955-5007-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SODIUM BORATE91MBZ8H3QOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
LYTTA VESICATORIA3Q034RO3BTACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
CANIS LUPUS FAMILIARIS MILKG39P120JQTACTIB
PULSATILLA PRATENSIS8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
52eb9753-3a92-4b1b-918d-82154397022832b47a06-72ef-4d73-9faf-d6488ea84ac32016-06-24WarningsExact identifier
spl id: 52eb9753-3a92-4b1b-918d-821543970228
spl set id: 32b47a06-72ef-4d73-9faf-d6488ea84ac3

Reported adverse events (FAERS/openFDA)#

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