NDC 55714-4506

Breast 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

Breast Care - Fibrocystic is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Newton Laboratories, Inc.. The primary component is Bufo Bufo Cutaneous Gland; Apis Mellifera; Asterias Rubens; Atropa Belladonna; Bryonia Alba Root; Oyster Shell Calcium Carbonate, Crude; Matricaria Recutita; 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; Pulsatilla Vulgaris; Sanguinaria Canadensis Root; Silicon Dioxide; Hamamelis Virginiana Root Bark/stem Bark; Ruta Graveolens Flowering Top; Taraxacum Officinale.

• Product ID: 55714-4506_c8a13ce2-5e25-2b64-7cf1-dcbb9ea8b3db
• NDC: 55714-4506
• Product Type: Human Prescription Drug
• Proprietary 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
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2011-06-01
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Newton Laboratories, Inc.
• Substance Name: BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; 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; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE
• Active Ingredient Strength: 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
• Pharm Classes: Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55714-4506-1

29.57 mL in 1 BOTTLE, GLASS (55714-4506-1)

• Marketing Start Date: 2011-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55714-4506-1 [55714450601]

Breast Care - Fibrocystic LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-06-01
• Marketing End Date: 2019-01-31

NDC 55714-4506-2 [55714450602]

Breast Care - Fibrocystic LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-02-10
• Marketing End Date: 2019-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BUFO BUFO CUTANEOUS GLAND	15 [hp_X]/mL

OpenFDA Data

• SPL SET ID: e670f465-1d21-f729-cf8e-b58707dd4f41
• Manufacturer:
  • Newton Laboratories, Inc.
• UNII:
  • DQV54Y5H3U
  • T7J046YI2B
  • I76KB35JEV
  • N94C2U587S
  • 0HK2GZK66E
  • 4N9P6CC1DX
  • 11E6VI8VEG
  • ETJ7Z6XBU4
  • FXS1BY2PGL
  • S003A158SB
  • WCK21A9W9J
  • Q28R5GF371
  • VSW71SS07I
  • 2E32821G6I
  • 7S82P3R43Z
  • G0R4UBI2ZZ
  • T7S323PKJS
  • N4LEE4Z93J
  • WQZ3G9PF0H
  • Q59QU6N72Q
  • A7FYY9Q742
  • 39981FM375
  • N9288CD508
  • 4QQN74LH4O
  • 27YLU75U4W

Pharmacological Class

• Standardized Insect Venom Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Allergens [CS]
• Bee Venoms [CS]

NDC Crossover Matching brand name "Breast Care - Fibrocystic" or 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"

NDC	Brand Name	Generic Name
55714-4506	Breast 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
55714-4507	Breast 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
55714-4828	Breast 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