NDC 35781-0210

SPEEDGEL RX

Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale

SPEEDGEL RX is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Gensco Laboratories, Llc. The primary component is Echinacea Angustifolia; Echinacea Purpurea; Aconitum Napellus; Arnica Montana; Calendula Officinalis Flowering Top; Hamamelis Virginiana Root Bark/stem Bark; Atropa Belladonna; Bellis Perennis; Chamomile; Achillea Millefolium; Hypericum Oil; Comfrey Root; Colchicine; Ginger.

• Product ID: 35781-0210_46f83cb3-88af-46fa-89a8-c6a40179fd62
• NDC: 35781-0210
• Product Type: Human Prescription Drug
• Proprietary Name: SPEEDGEL RX
• Generic Name: Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2011-12-01
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Gensco Laboratories, LLC
• Substance Name: ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER
• Active Ingredient Strength: 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
• Pharm Classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],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: 2021-12-31

Packaging

NDC 35781-0210-1

1 BOTTLE, DISPENSING in 1 CARTON (35781-0210-1) > 10 mL in 1 BOTTLE, DISPENSING

• Marketing Start Date: 2011-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35781-0210-1 [35781021001]

SPEEDGEL RX GEL

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-12-01

NDC 35781-0210-9 [35781021009]

SPEEDGEL RX GEL

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-12-01

NDC 35781-0210-2 [35781021002]

SPEEDGEL RX GEL

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-12-01

Drug Details

Active Ingredients

Ingredient	Strength
ECHINACEA ANGUSTIFOLIA	1 [hp_X]/30mL

OpenFDA Data

• SPL SET ID: abc4b132-4d35-46a4-9a8e-9bd4c7a0f4b0
• Manufacturer:
  • Gensco Laboratories, LLC
• UNII:
  • C5529G5JPQ
  • QI7G114Y98
  • M9VVZ08EKQ
  • OZU2FC70HY
  • O80TY208ZW
  • FGL3685T2X
  • WQZ3G9PF0H
  • 2HU33I03UY
  • 18E7415PXQ
  • SML2Y3J35T
  • 2FXJ6SW4PK
  • T7S323PKJS
  • VB06AV5US8
  • U0NQ8555JD
• UPC Code:
  • 0335781021013

Pharmacological Class

• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Interactions [MoA]
• 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 "SPEEDGEL RX" or generic name "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum, Symphytum Officinale, Colchicinum, Zingiber Officinale"

NDC	Brand Name	Generic Name
35356-647	speedgel rx	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
35781-0210	SPEEDGEL RX	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
50436-9072	SPEEDGEL RX	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
50436-9074	SPEEDGEL RX	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
53149-9074	SPEEDGEL RX	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE
69176-070	Rapid Gel Rx	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE