83027-0007 NDC - COLD SORE FORMULA (DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE)

Drug Information

Product NDC: 83027-0007
Proprietary Name: Cold Sore Formula
Non Proprietary Name: Dulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Muriaticum, Aconitum Napellus, Cytomegalovirus Nosode, Herpes Simplex I and II Nosode, Sepia, Epstein Barr Virus Nosode, Herpes Zoster Nosode, Adenoviren Nosode
Active Ingredient(s): 15 [hp_X]/mL ACONITUM NAPELLUS WHOLE; 8 [hp_X]/mL FAGOPYRUM ESCULENTUM WHOLE; 3 [hp_X]/mL GLYCYRRHIZA GLABRA; 20 [hp_C]/mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; 18 [hp_X]/mL HUMAN HERPESVIRUS 1; 18 [hp_X]/mL HUMAN HERPESVIRUS 2; 18 [hp_C]/mL HUMAN HERPESVIRUS 3; 15 [hp_C]/mL HUMAN HERPESVIRUS 4; 15 [hp_X]/mL HUMAN HERPESVIRUS 5; 3 [hp_X]/mL RANUNCULUS BULBOSUS WHOLE; 30 [hp_X]/mL SEPIA OFFICINALIS JUICE; 6 [hp_X]/mL SODIUM CHLORIDE; 12 [hp_X]/mL SODIUM HYPOCHLORITE; 3 [hp_X]/mL SOLANUM DULCAMARA TOP; 5 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF
Administration Route(s): ORAL
Dosage Form(s): SPRAY
Pharmacy Class(es): Actively Acquired Immunity [PE]; Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Live Human Adenovirus Type 4 Vaccine [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Vaccines; Adenovirus [Chemical/Ingredient]; Vaccines; Live; Unattenuated [Chemical/Ingredient]

Labeler Information

Field Name	Field Value
Labeler Name:	Nutritional Specialties, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/30/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	83027-0007-1	60 mL in 1 BOTTLE, SPRAY (83027-0007-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	83027-0007	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Cold Sore Formula	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Dulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Muriaticum, Aconitum Napellus, Cytomegalovirus Nosode, Herpes Simplex I and II Nosode, Sepia, Epstein Barr Virus Nosode, Herpes Zoster Nosode, Adenoviren Nosode	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SPRAY	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/30/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Nutritional Specialties, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACONITUM NAPELLUS WHOLE; FAGOPYRUM ESCULENTUM WHOLE; GLYCYRRHIZA GLABRA; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; RANUNCULUS BULBOSUS WHOLE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SODIUM HYPOCHLORITE; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	15; 8; 3; 20; 18; 18; 18; 15; 15; 3; 30; 6; 12; 3; 5
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Actively Acquired Immunity [PE], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Live Human Adenovirus Type 4 Vaccine [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]

Drug Information

Labeler Information

Package Information

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