Arnica Gel 15 Gel
NDC 80004-400

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 80004-400?
  5. Arnica Gel 15 Arnica Montana 1x Hpus Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

Arnica Gel 15 (arnica gel) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Vitamedica, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white gel for topical administration. This product entry covers the primary NDC 80004-400 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
80004-400
Proprietary Name:
Arnica Gel 15 Arnica Montana 1x Hpus
Non-Proprietary Name: [1]
Arnica Gel
Substance Name: [2]
Achillea Millefolium Flower; Arnica Montana Flower; Arnica Montana Whole; Belladonna Leaf; Bellis Perennis Flower; Calendula Officinalis Flowering Top; Hamamelis Virginiana Bark; Hypericum Perforatum; Ledum Palustre Whole; Rhus Typhina Whole; Ruta Graveolens Whole; Symphytum Officinale Whole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 & Regulatory Data

Labeler Name: [5]
Vitamedica, Inc.
Labeler Code:
80004
Product Label ID:
4e56ff37-e260-be18-e063-6294a90aaced
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
03-01-2024
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - GEL)

Code Structure Chart

Product Details

What is NDC 80004-400?

The NDC code 80004-400 is assigned by the FDA to the product Arnica Gel 15 Arnica Montana 1x Hpus. It is commonly known by its generic name, arnica gel. This pharmaceutical product is labeled by Vitamedica, Inc. and is currently categorized as listed product. The medication is a gel administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 80004-400-40. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

What are Active Ingredients of this product?

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 the associated UNII Codes?

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

  • HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
  • HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (Active Moiety)
  • SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)
  • SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (Active Moiety)
  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW)
  • ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (Active Moiety)
  • RHUS TYPHINA WHOLE (UNII: Y465D8AABT)
  • RHUS TYPHINA WHOLE (UNII: Y465D8AABT) (Active Moiety)
  • HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
  • HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (Active Moiety)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
  • CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (Active Moiety)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (Active Moiety)
  • LEDUM PALUSTRE WHOLE (UNII: 1N8KG72C5M)
  • LEDUM PALUSTRE WHOLE (UNII: 1N8KG72C5M) (Active Moiety)
  • ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
  • ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (Active Moiety)
  • BELLADONNA LEAF (UNII: 6GZW20TIOI)
  • BELLADONNA LEAF (UNII: 6GZW20TIOI) (Active Moiety)
  • BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
  • BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) (Active Moiety)
  • RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P)
  • RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (Active Moiety)

Which are the Inactive Ingredients associated 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:

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".