FDA.reportPublic FDA data

Breast Care - Fibrocystic

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:13:42

Label at a glance#

ProductBreast Care - Fibrocystic
Active ingredientBUFO BUFO CUTANEOUS GLAND, APIS MELLIFERA, ASTERIAS RUBENS, ATROPA BELLADONNA, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA OFFICINALIS BARK, CONIUM MACULATUM FLOWERING TOP, CROTON TIGLIUM SEED, ECHINACEA, UNSPECIFIED, GRAPHITE, CHAMAELIRIUM LUTEUM ROOT, LACHESIS MUTA VENOM, MERCURY, OENANTHE AQUATICA FRUIT, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, ANEMONE PULSATILLA, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, RUTA GRAVEOLENS FLOWERING TOP, TARAXACUM OFFICINALE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.

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 Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 15x.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4828-1Breast Care - Fibrocystic30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4828BREAST CARE - FIBROCYSTIC (BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20201203_98d01128-9887-12ce-e053-2a95a90a7329.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-482855714-4828-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUFO BUFO CUTANEOUS GLANDQ59QU6N72QACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ASTERIAS RUBENSA7FYY9Q742ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CHIMAPHILA UMBELLATAWCK21A9W9JACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GRAPHITE4QQN74LH4OACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURYFXS1BY2PGLACTIB
OENANTHE AQUATICA FRUITN4LEE4Z93JACTIB
PHOSPHORUS27YLU75U4WACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
TARAXACUM OFFICINALE39981FM375ACTIB

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
Breast Care - FibrocysticBUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUMNewton Laboratories, Inc.98d01128-9887-12ce-e053-2a95a90a73292020-12-02WarningsExact identifier
ndc (package): 55714-4828-1
ndc (product): 55714-4828
ndc11 (package): 55714482801
spl id: b5804ae4-1b82-3f5f-e053-2a95a90a440d
spl set id: 98d01128-9887-12ce-e053-2a95a90a7329

Reported adverse events (FAERS/openFDA)#

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