Breast Care - Fibrocystic

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Breast Care - Fibrocystic
Generic name: 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
Manufacturer: Newton Laboratories, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 98d01128-9887-12ce-e053-2a95a90a7329
SPL ID: b5804ae4-1b82-3f5f-e053-2a95a90a440d
Version: 3
Effective date: 2020-12-02
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:55

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 33 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Breast Care - Fibrocystic	openfda.brand_name
generic name		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	openfda.generic_name
manufacturer name		Newton Laboratories, Inc.	openfda.manufacturer_name
ndc	package	55714-4828-1	openfda.package_ndc
ndc	product	55714-4828	openfda.product_ndc
ndc11	package	55714482801	derived:openfda.package_ndc
spl id		b5804ae4-1b82-3f5f-e053-2a95a90a440d	id
spl set id		98d01128-9887-12ce-e053-2a95a90a7329	set_id
unii		27YLU75U4W	openfda.unii
unii		11E6VI8VEG	openfda.unii
unii		4QQN74LH4O	openfda.unii
unii		WCK21A9W9J	openfda.unii
unii		Q28R5GF371	openfda.unii
unii		FXS1BY2PGL	openfda.unii
unii		39981FM375	openfda.unii
unii		N94C2U587S	openfda.unii
unii		ETJ7Z6XBU4	openfda.unii
unii		2E32821G6I	openfda.unii
unii		Q59QU6N72Q	openfda.unii
unii		A7FYY9Q742	openfda.unii
unii		N4LEE4Z93J	openfda.unii
unii		4N9P6CC1DX	openfda.unii
unii		S003A158SB	openfda.unii
unii		WQZ3G9PF0H	openfda.unii
unii		T7J046YI2B	openfda.unii
unii		VSW71SS07I	openfda.unii
unii		0HK2GZK66E	openfda.unii
unii		7S82P3R43Z	openfda.unii
unii		N9288CD508	openfda.unii
unii		G0R4UBI2ZZ	openfda.unii
unii		DQV54Y5H3U	openfda.unii
unii		I76KB35JEV	openfda.unii
unii		T7S323PKJS	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

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