NDC 51393-6657 H-balm Control Extra Strength

Calendula Officinalis Flowering Top,Echinacea,Sodium Chloride,And Thuja Occidentalis Leafy - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51393-6657
Proprietary Name:
H-balm Control Extra Strength
Non-Proprietary Name: [1]
Calendula Officinalis Flowering Top, Echinacea, Sodium Chloride, And Thuja Occidentalis Leafy Twig
Substance Name: [2]
Calendula Officinalis Flowering Top; Echinacea, Unspecified; Sodium Chloride; Thuja Occidentalis Leafy Twig
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Forces Of Nature
    Labeler Code:
    51393
    Marketing Category: [8]
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date: [9]
    04-06-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)

    Product Packages

    NDC Code 51393-6657-1

    Package Description: 11 mL in 1 BOTTLE, DISPENSING

    NDC Code 51393-6657-2

    Package Description: 33 mL in 1 BOTTLE, DISPENSING

    NDC Code 51393-6657-4

    Package Description: 4 mL in 1 BOTTLE

    Product Details

    What is NDC 51393-6657?

    The NDC code 51393-6657 is assigned by the FDA to the product H-balm Control Extra Strength which is a human over the counter drug product labeled by Forces Of Nature. The generic name of H-balm Control Extra Strength is calendula officinalis flowering top, echinacea, sodium chloride, and thuja occidentalis leafy twig. The product's dosage form is solution/ drops and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 51393-6657-1 11 ml in 1 bottle, dispensing , 51393-6657-2 33 ml in 1 bottle, dispensing , 51393-6657-4 4 ml in 1 bottle . 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 H-balm Control Extra Strength?

    Shake well before use. Apply 2-3 drops on a moistened swap and dab to problem area 3-4 times per day during an outbreak. For best result: Immediately and often at the very first signs of an outbreak or when you feel one coming on. Use of this product during prodrome (tingling some experience before an outbreak) may improve results. Apply to the soles of feet 3 times per day for systemic support. Wash hands after use. Avoid contact with eyes. For children under 2 years of age, consult a doctor before use.

    What are H-balm Control Extra Strength 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 H-balm Control Extra Strength UNII Codes?

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

    • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
    • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)
    • ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
    • ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (Active Moiety)
    • SODIUM CHLORIDE (UNII: 451W47IQ8X)
    • SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
    • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397)
    • THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (Active Moiety)

    Which are H-balm Control Extra Strength 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 H-balm Control Extra Strength?

    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".