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  4. NDC Product Code: 83027-0007 Cold Sore Formula

NDC 83027-0007 Cold Sore Formula

Dulcamara,Glycyrrhiza Glabra,Ranunculus Bulbosus,Rhus Tox,Natrum Muriaticum,Fagopyrum - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83027-0007?
  4. Cold Sore Formula Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83027-0007
Proprietary Name:
Cold Sore Formula
Non-Proprietary Name: [1]
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
Substance Name: [2]
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
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Nutritional Specialties, Inc.
    Labeler Code:
    83027
    Product Label ID:
    f4e7e469-baaf-4c61-af44-80b0832eadf0
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    03-30-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 83027-0007-1

    Package Description: 60 mL in 1 BOTTLE, SPRAY

    Product Details

    What is NDC 83027-0007?

    The NDC code 83027-0007 is assigned by the FDA to the product Cold Sore Formula which is a human over the counter drug product labeled by Nutritional Specialties, Inc.. The generic name of Cold Sore Formula is 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 product's dosage form is spray and is administered via oral form. The product is distributed in a single package with assigned NDC code 83027-0007-1 60 ml in 1 bottle, spray . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cold Sore Formula?

    Adults: Acute 2 to 3 sprays orally every hour, up to 48 hours. Then 2 to 3 sprays three times per day. Chronic and maintenance 1 to 2 sprays four times daily. Can be sprayed directly on afflicted areas in conjunction with oral use. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

    What are Cold Sore Formula Active Ingredients?

    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.

    Which are Cold Sore Formula UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • SOLANUM DULCAMARA TOP (UNII: KPS1B1162N)
    • SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (Active Moiety)
    • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
    • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (Active Moiety)
    • RANUNCULUS BULBOSUS WHOLE (UNII: AEQ8NXJ0MB)
    • RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (Active Moiety)
    • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A)
    • TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (Active Moiety)
    • SODIUM CHLORIDE (UNII: 451W47IQ8X)
    • CHLORIDE ION (UNII: Q32ZN48698) (Active Moiety)
    • FAGOPYRUM ESCULENTUM WHOLE (UNII: B10M69172N)
    • FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (Active Moiety)
    • SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
    • HYPOCHLORITE ION (UNII: T5UM7HB19N) (Active Moiety)
    • ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD)
    • ACONITUM NAPELLUS (UNII: U0NQ8555JD) (Active Moiety)
    • HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K)
    • HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (Active Moiety)
    • HUMAN HERPESVIRUS 1 (UNII: 22G38P19RL)
    • HUMAN HERPESVIRUS 1 (UNII: 22G38P19RL) (Active Moiety)
    • HUMAN HERPESVIRUS 2 (UNII: 74J6DNH49U)
    • HUMAN HERPESVIRUS 2 (UNII: 74J6DNH49U) (Active Moiety)
    • SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2)
    • SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (Active Moiety)
    • HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX)
    • HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX) (Active Moiety)
    • HUMAN HERPESVIRUS 3 (UNII: 9885M7D6JP)
    • HUMAN HERPESVIRUS 3 (UNII: 9885M7D6JP) (Active Moiety)
    • HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN (UNII: FKD3DUK39I)
    • HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 (UNII: FKD3DUK39I) (Active Moiety)

    Which are Cold Sore Formula Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Cold Sore Formula?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - 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.

    [3] What kind of product is this? - 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".