NDC 55714-4440

Oral Care - Gingivitis

Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus,crotalus Horridus, Gelsemium, Hepar Sulph.calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Slicea, Staphysag., Echinacea

Oral Care - Gingivitis is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Newton Laboratories, Inc.. The primary component is Aconitum Napellus; Arnica Montana; Arsenic Trioxide; Baptisia Tinctoria Root; Atropa Belladonna; Bryonia Alba Root; Calendula Officinalis Flowering Top; Matricaria Recutita; Chelidonium Majus; Crotalus Horridus Horridus Venom; Gelsemium Sempervirens Root; Calcium Sulfide; Wood Creosote; Mercury; Myrrh; Strychnos Nux-vomica Seed; Phosphorus; Plantago Major; Toxicodendron Pubescens Leaf; Silicon Dioxide; Delphinium Staphisagria Seed; Echinacea, Unspecified.

• Product ID: 55714-4440_ad1ee35c-b45f-d330-cec0-c89d14c1bd24
• NDC: 55714-4440
• Product Type: Human Prescription Drug
• Proprietary Name: Oral Care - Gingivitis
• Generic Name: Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus,crotalus Horridus, Gelsemium, Hepar Sulph.calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Slicea, Staphysag., Echinacea
• 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: ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; WOOD CREOSOTE; MERCURY; MYRRH; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED
• Active Ingredient Strength: 20 [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: Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55714-4440-1

29.57 mL in 1 BOTTLE, GLASS (55714-4440-1)

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

NDC SPL Data Element Entries

NDC 55714-4440-2 [55714444002]

Oral Care - Gingivitis LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-02-05
• Inactivation Date: 2020-01-31

NDC 55714-4440-1 [55714444001]

Oral Care - Gingivitis LIQUID

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-06-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ACONITUM NAPELLUS	20 [hp_X]/mL

OpenFDA Data

• SPL SET ID: 2253bc11-fcc5-32e2-ad5b-a14d31e1772d
• Manufacturer:
  • Newton Laboratories, Inc.
• UNII:
  • 18E7415PXQ
  • 5EF0HWI5WU
  • ETJ7Z6XBU4
  • O80TY208ZW
  • 6IO182RP7A
  • JC71GJ1F3L
  • 639KR60Q1Q
  • T7J046YI2B
  • 4N9P6CC1DX
  • W2469WNO6U
  • U0NQ8555JD
  • FXS1BY2PGL
  • G0R4UBI2ZZ
  • S7V92P67HO
  • 7E889U5RNN
  • WQZ3G9PF0H
  • YHA2XLJ956
  • 3JYG22FD73
  • 269XH13919
  • 1MBW07J51Q
  • 00543AP1JV
  • 27YLU75U4W

Pharmacological Class

• Non-Standardized Plant Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Allergens [CS]
• Plant Proteins [CS]
• Seed Storage Proteins [CS]

NDC Crossover Matching brand name "Oral Care - Gingivitis" or generic name "Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus,crotalus Horridus, Gelsemium, Hepar Sulph.calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Slicea, Staphysag., Echinacea"

NDC	Brand Name	Generic Name
55714-4440	Oral Care - Gingivitis	Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea
55714-4441	Oral Care - Gingivitis	Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea