NDC 55714-4448

Menstrual - PMS

Angelica Sinensis Radix, Arsenicum Alb., Bryonia, Caulophyllum, Cimicifuga,cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux Vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum Op., Zingiber, Echinacea, Valeriana

Menstrual - PMS is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Newton Laboratories, Inc.. The primary component is Angelica Sinensis Root; Arsenic Trioxide; Bryonia Alba Root; Caulophyllum Thalictroides Root; Black Cohosh; Cinchona Officinalis Bark; Dioscorea Villosa Tuber; Estrone; Gelsemium Sempervirens Root; Lachesis Muta Venom; Lilium Lancifolium Whole Flowering; Lycopodium Clavatum Spore; Achillea Millefolium; Strychnos Nux-vomica Seed; Pulsatilla Vulgaris; Juniperus Sabina Leafy Twig; Claviceps Purpurea Sclerotium; Sepia Officinalis Juice; Capsella Bursa-pastoris; Viburnum Opulus Bark; Ginger; Echinacea, Unspecified; Valerian.

• Product ID: 55714-4448_5c513c5f-7684-2373-1576-8affbd383cc0
• NDC: 55714-4448
• Product Type: Human Prescription Drug
• Proprietary Name: Menstrual - PMS
• Generic Name: Angelica Sinensis Radix, Arsenicum Alb., Bryonia, Caulophyllum, Cimicifuga,cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux Vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum Op., Zingiber, Echinacea, Valeriana
• 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: ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; GINGER; ECHINACEA, UNSPECIFIED; VALERIAN
• 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; [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],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55714-4448-2

59.14 mL in 1 BOTTLE, GLASS (55714-4448-2)

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

NDC SPL Data Element Entries

NDC 55714-4448-2 [55714444802]

Menstrual - PMS LIQUID

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

NDC 55714-4448-1 [55714444801]

Menstrual - PMS 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
ANGELICA SINENSIS ROOT	20 [hp_X]/mL

OpenFDA Data

• SPL SET ID: e534e352-d92e-4aa1-b739-c818e80c2e2e
• Manufacturer:
  • Newton Laboratories, Inc.
• UNII:
  • JWF5YAW3QW
  • T7J046YI2B
  • I76KB35JEV
  • 639KR60Q1Q
  • 4N9P6CC1DX
  • K73E24S6X9
  • S003A158SB
  • C88X29Y479
  • QDL83WN8C2
  • IWY3IWX2G8
  • VSW71SS07I
  • T1UG6H6805
  • X67Z2963PI
  • C5529G5JPQ
  • 01G9XEA93N
  • B66F4574UG
  • S7V92P67HO
  • 269XH13919
  • W0X9457M59
  • 2FXJ6SW4PK
  • Z5BEX9K2G1
  • 2DI9HA706A
  • JTJ6HH6YEH

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]
• Non-Standardized Plant Allergenic Extract [EPC]
• Non-Standardized Food Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Plant Proteins [CS]
• Food Additives [CS]

NDC Crossover Matching brand name "Menstrual - PMS" or generic name "Angelica Sinensis Radix, Arsenicum Alb., Bryonia, Caulophyllum, Cimicifuga,cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux Vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum Op., Zingiber, Echinacea, Valeriana"

NDC	Brand Name	Generic Name
55714-2222	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-2223	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-2481	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-2482	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-4448	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-4449	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana
55714-4749	Menstrual - PMS	Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana