FDA.reportPublic FDA data

Fem Response

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:36:08

Label at a glance#

ProductFem Response
Active ingredientAPOCYNUM CANNABINUM ROOT, ARALIA RACEMOSA ROOT, BELLIS PERENNIS, PAPAYA SEED, CUPRIC ARSENITE, LACTIC ACID, DL-, JUNIPERUS SABINA LEAFY TWIG, WYETHIA HELENIOIDES ROOT
Label structure8 sections

Label contents#

Full prescribing information#

Fem Response

OTC - ACTIVE INGREDIENT SECTION

Apocynum Cannabinum 7X                Cuprum Arsenicosum 10X

Aralia Racemosa 15X, 30X                 Lacticum Acidum 10X

Bellis Perennis 10X, 20X                    Sabina 20X

Carica Papata 8C                              Wyethia Heleniodes 30X

Fem Response

INACTIVE INGREDIENT SECTION

Alcohol, Purified Water

Fem Response

WARNINGS SECTION

Use only under the direction of a health care professional. Do not use if tamper evident seal is broke or missing.

Fem Response

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Fem Response

INDICATIONS & USAGE SECTION

For the temporary relief of hot flashes, confusion, irritability, syptoms of premenses, abnormal menstrual function and pelvic pain and discomfort.

Fem Response

DOSAGE & ADMINISTRATION SECTION

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

Fem Response

OTC - PURPOSE SECTION

Helps ease hot flashes, confusion, irritability symptoms of premenses, abnormal menstrual function and pelvic pain and discomfort.

Fem Response

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-091-02Fem Response59 mL in 1 BOTTLE, DROPPERLIQUID598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APOCYNUM CANNABINUM ROOTACTIVE INGREDIENT2F92409L9Z1
ARALIA RACEMOSA ROOTACTIVE INGREDIENTT90W4582DU1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
CUPRIC ARSENITEACTIVE INGREDIENTSK8L60BCSQ1
JUNIPERUS SABINA LEAFY TWIGACTIVE INGREDIENTZ5BEX9K2G11
LACTIC ACID, DL-ACTIVE INGREDIENT3B8D35Y7S41
PAPAYA SEEDACTIVE INGREDIENT2ZN3FO349A1
WYETHIA HELENIOIDES ROOTACTIVE INGREDIENTJ10PD1AQ0N1
APOCYNUM CANNABINUM ROOTACTIVE MOIETY2F92409L9Z1
ARALIA RACEMOSA ROOTACTIVE MOIETYT90W4582DU1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
JUNIPERUS SABINA LEAFY TWIGACTIVE MOIETYZ5BEX9K2G11
LACTIC ACID, DL-ACTIVE MOIETY3B8D35Y7S41
PAPAYA SEEDACTIVE MOIETY2ZN3FO349A1
WYETHIA HELENIOIDES ROOTACTIVE MOIETYJ10PD1AQ0N1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-09164616-091-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
APOCYNUM CANNABINUM ROOT2F92409L9ZACTIB
ARALIA RACEMOSA ROOTT90W4582DUACTIB
BELLIS PERENNIS2HU33I03UYACTIB
PAPAYA SEED2ZN3FO349AACTIB
CUPRIC ARSENITESK8L60BCSQACTIB
LACTIC ACID, DL-3B8D35Y7S4ACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
WYETHIA HELENIOIDES ROOTJ10PD1AQ0NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 ResponseFEMALE REPRODUCTIVE BOOSTERVitality Works, Inc.4a1693e2-b514-4dc8-9397-d255defc70cd2025-12-17WarningsExact identifier
ndc (package): 64616-091-02
ndc (product): 64616-091
ndc11 (package): 64616009102
spl id: 462f4a5d-6e0f-de9a-e063-6394a90a7768
spl set id: 4a1693e2-b514-4dc8-9397-d255defc70cd

Reported adverse events (FAERS/openFDA)#

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