Inflamyar Ointment
NDC 59469-148

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 59469-148?
  4. Inflamyar Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

Inflamyar (arnica montana root, bryonia dioica root, guaiacum officinale resin, toxicodendron pubescens shoot, bellis perennis, ledum palustre twig, ruta graveolens flowering top, and viscum album fruiting top) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Pekana Naturheilmittel Gmbh. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a ointment for cutaneous administration. This product entry covers the primary NDC 59469-148 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
59469-148
Proprietary Name:
Inflamyar
Non-Proprietary Name: [1]
Arnica Montana Root, Bryonia Dioica Root, Guaiacum Officinale Resin, Toxicodendron Pubescens Shoot, Bellis Perennis, Ledum Palustre Twig, Ruta Graveolens Flowering Top, And Viscum Album Fruiting Top
Substance Name: [2]
Arnica Montana Root; Bellis Perennis Whole; Bryonia Dioica Root; Guaiacum Officinale Resin; Rhododendron Tomentosum Leafy Twig; Ruta Graveolens Flowering Top; Toxicodendron Pubescens Shoot; Viscum Album Fruiting Top
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
Cutaneous - Administration to the skin.

Labeler & Regulatory Data

Labeler Name: [5]
Pekana Naturheilmittel Gmbh
Labeler Code:
59469
Product Label ID:
5852fec1-b05f-4e06-ba3b-8aae9f2d55e5
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
04-12-2008
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 59469-148?

The NDC code 59469-148 is assigned by the FDA to the product Inflamyar. It is commonly known by its generic name, arnica montana root, bryonia dioica root, guaiacum officinale resin, toxicodendron pubescens shoot, bellis perennis, ledum palustre twig, ruta graveolens flowering top, and viscum album fruiting top. This pharmaceutical product is labeled by Pekana Naturheilmittel Gmbh and is currently categorized as listed product. The medication is a ointment administered via cutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 59469-148-30, 59469-148-40. 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?

Unless otherwise prescribed, apply a moderate amount of ointment 2 to 3 times per day by rubbing gently into the affected area.

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:

  • ARNICA MONTANA ROOT (UNII: MUE8Y11327)
  • ARNICA MONTANA ROOT (UNII: MUE8Y11327) (Active Moiety)
  • BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX)
  • BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (Active Moiety)
  • GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6)
  • GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (Active Moiety)
  • TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M)
  • TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M) (Active Moiety)
  • BELLIS PERENNIS (UNII: 2HU33I03UY)
  • BELLIS PERENNIS (UNII: 2HU33I03UY) (Active Moiety)
  • RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P)
  • RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (Active Moiety)
  • RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S)
  • RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (Active Moiety)
  • VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
  • VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (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".