83027-0303 NDC - COLD SORE FORMULA (DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE)

Drug Information

  • Product NDC: 83027-0303
  • Proprietary Name: Cold Sore Formula
  • Non Proprietary Name: Dulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Hypochlorous, 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 (LICORICE) ROOT POWDER; 20 [hp_C]/mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; 20 [hp_X]/mL HUMAN HERPESVIRUS 1; 20 [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:3/31/2026

Package Information

No. Package Code Package Description Billing Unit
183027-0303-160 mL in 1 BOTTLE, SPRAY (83027-0303-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83027-0303The 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 NAMEHUMAN OTC DRUGIndicates 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 NAMECold Sore FormulaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Hypochlorous, Aconitum Napellus, Cytomegalovirus Nosode, Herpes Simplex I and II Nosode, Sepia, Epstein Barr Virus Nosode, Herpes Zoster Nosode, Adenoviren NosodeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/31/2026This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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 NAMENutritional Specialties, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS WHOLE; FAGOPYRUM ESCULENTUM WHOLE; GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER; 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 LEAFAn 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 STRENGTH15; 8; 3; 20; 20; 20; 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 CLASSESActively 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] 

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This page was last updated on: 5/7/2026

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