FDA.reportPublic FDA data

Female Femroids

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:48

Label at a glance#

ProductFemale Femroids
Active ingredientGOLDENSEAL, USTILAGO MAYDIS, ARSENIC TRIOXIDE, CALCIUM IODIDE, CARBO ANIMALIS, CONIUM MACULATUM FLOWERING TOP, GRAPHITE, IODINE, WOOD CREOSOTE, LACHESIS MUTA VENOM, PHOSPHORUS, JUNIPERUS SABINA LEAFY TWIG, CLAVICEPS PURPUREA SCLEROTIUM, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, CAPSELLA BURSA-PASTORIS, THUJA OCCIDENTALIS LEAFY TWIG, THYROID, UNSPECIFIED, TRILLIUM ERECTUM ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hydrastis canadensis 6x, Thuja occidentalis 6x, Arsenicum album 15x, Calcarea iodata 15x, Carbo animalis 15x, Conium maculatum 15x, Graphites 15x, Hydrastis canadensis 15x, Iodium 15x, Kreosotum 15x, Lachesis mutus 15x, Phosphorus 15x, Sabina 15x, Secale cornutum 15x, Sepia 15x, Silicea 15x, Thlaspi bursa-pastoris 15x, Thuja occidentalis 15x, Thyroidinum 15x, Trillium pendulum 15x, Ustilago maidis 1

OTC - PURPOSE SECTION

Formulated for symptoms such as heavy or prolonged menses and/or pelvic discomfort.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4769-1Female Femroids30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4769FEMALE FEMROIDS (HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201204_9a01acb9-1b2b-3a33-e053-2995a90adc92.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
55714-476955714-4769-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
GOLDENSEALZW3Z11D0JVACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CALCIUM IODIDE8EKI9QEE2HACTIB
CARBO ANIMALIS279O8I0433ACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
GRAPHITE4QQN74LH4OACTIB
IODINE9679TC07X4ACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
PHOSPHORUS27YLU75U4WACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
CAPSELLA BURSA-PASTORISW0X9457M59ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
TRILLIUM ERECTUM ROOTAHW6F0T2X0ACTIB
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
Female FemroidsHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, ARSENICUM ALBUM, CALCAREA IODATA, CARBO ANIMALIS, CONIUM MACULATUM, GRAPHITES, HYDRASTIS CANADENSIS, IODIUM, KREOSOTUM, LACHESIS MUTUS, PHOSPHORUS, SABINA, SECALE CORNUTUM, SEPIA, SILICEA, THLASPI BURSA-PASTORIS, THUJA OCCIDENTALIS, THYROIDINUM, TRILLIUM PENDULUM, USTILAGO MAIDIS.Newton Laboratories, Inc.9a01acb9-1b2b-3a33-e053-2995a90adc922020-12-03WarningsExact identifier
ndc (package): 55714-4769-1
ndc (product): 55714-4769
ndc11 (package): 55714476901
spl id: b592ade1-a61b-0588-e053-2995a90aa070
spl set id: 9a01acb9-1b2b-3a33-e053-2995a90adc92

Reported adverse events (FAERS/openFDA)#

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