FDA.reportPublic FDA data

Menopause Relief

Manufacturer
King Bio Inc
Effective date
2012-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:43

Label at a glance#

ProductMenopause Relief
Active ingredientAMYL NITRITE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, IRON, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, PULSATILLA VULGARIS, SANGUINARIA CANADENSIS ROOT, SEPIA OFFICINALIS JUICE, SULFUR, SULFURIC ACID
Label structure8 sections

Indications and uses

For fast relief of symptoms: hot flashes, sweats, chills, clammy skin, heat in the head, headaches, hot feet, mood swings, sensitivity, anxiety, wanting to be alone. Reference image menopauserelief.jpg

Dosage and administration

Directions:  Initially, depress pump until primed.  Hold close to mouth and spray one dose directly into mouth.  Use 3 times per day.  Use additionally as needed. Adult Dose - 3 Pump Sprays Children (2-12 Years) - 2 Pump Sprays Reference image menopauserelief.jpg

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Official HPUS:  Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum.

Reference image menopauserelief.jpg

Purpose

OTC - PURPOSE SECTION

for fast relief of symptoms:

  • hot flashes
  • sweats
  • chills
  • clammy skin
  • heat in the head
  • headaches
  • hot feet
  • mood swings
  • sensitivity
  • anxiety
  • wanting to be alone
Reference image menopauserelief.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Reference image menopauserelief.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional.  Keep out of reach of children.

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

Reference image menopauserelief.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

For fast relief of symptoms: hot flashes, sweats, chills, clammy skin, heat in the head, headaches, hot feet, mood swings, sensitivity, anxiety, wanting to be alone.

Reference image menopauserelief.jpg

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warning: Keep out of reach of children.

Reference image menopauserelief.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions:  Initially, depress pump until primed.  Hold close to mouth and spray one dose directly into mouth.  Use 3 times per day.  Use additionally as needed.

Adult Dose - 3 Pump Sprays

Children (2-12 Years) - 2 Pump Sprays

Reference image menopauserelief.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of labelImage of label

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com


reference image menopauserelief.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6006-22020-01-31C16284748780-19d75b9cf-d5a7-f424-e053-dadaa90a57ceMenopause Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6006-2Menopause Relief59 mL in 1 BOTTLE, SPRAYSPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6006MENOPAUSE RELIEF (AMYL NITROSUM, CALCAREA CARBONICA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, PULSATILLA, SANGUINARIA CANADENSIS, SEPIA, SULPHUR, SULPHURICUM ACIDUM) SPRAY [KING BIO INC]1Legacy NDC, 1 package rows20120410_d25d8a15-52ed-43c2-ae59-f8cec33e75a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMYL NITRITEACTIVE INGREDIENT22T8Z09XAK1
BLACK COHOSHACTIVE INGREDIENTK73E24S6X91
CAULOPHYLLUM THALICTROIDES ROOTACTIVE INGREDIENTJTJ6HH6YEH1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
IRONACTIVE INGREDIENTE1UOL152H71
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SULFURACTIVE INGREDIENT70FD1KFU701
SULFURIC ACIDACTIVE INGREDIENTO40UQP6WCF1
AMYL NITRITEACTIVE MOIETY22T8Z09XAK1
BLACK COHOSHACTIVE MOIETYK73E24S6X91
CAULOPHYLLUM THALICTROIDES ROOTACTIVE MOIETYJTJ6HH6YEH1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
IRONACTIVE MOIETYE1UOL152H71
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SULFURACTIVE MOIETY70FD1KFU701
SULFURIC ACIDACTIVE MOIETYO40UQP6WCF1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-600657955-6006-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMYL NITRITE22T8Z09XAKACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
IRONE1UOL152H7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
SULFURIC ACIDO40UQP6WCFACTIB
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
344b2382-d8af-4b7d-93e8-a2ff11c71207d25d8a15-52ed-43c2-ae59-f8cec33e75a52012-03-07WarningsExact identifier
spl id: 344b2382-d8af-4b7d-93e8-a2ff11c71207
spl set id: d25d8a15-52ed-43c2-ae59-f8cec33e75a5

Reported adverse events (FAERS/openFDA)#

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