Dr. Reckeweg R35 Chadontin
NDC 53346-1335

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 53346-1335?
  4. Dr. Reckeweg R35 Chadontin Combination Product Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dr. Reckeweg R35 Chadontin is a UNAPPROVED HOMEOPATHIC-approved product labeled by Pharmazeutische Fabrik Dr. Reckeweg & Co. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 53346-1335 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53346-1335
Proprietary Name:
Dr. Reckeweg R35 Chadontin Combination Product
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Pharmazeutische Fabrik Dr. Reckeweg & Co
Labeler Code:
53346
Product Label ID:
dde18f16-8fff-40a7-acb3-c0b48cd2a7c2
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
06-01-1986
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 53346-1335?

The NDC code 53346-1335 is assigned by the FDA to the product Dr. Reckeweg R35 Chadontin Combination Product. This pharmaceutical product is labeled by Pharmazeutische Fabrik Dr. Reckeweg & Co and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 53346-1335-5. 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?

UsesFor the temporary relief of:Discomfort and pain associated with teething

Which are the associated UNII Codes?

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

  • ACONITUM NAPELLUS (UNII: U0NQ8555JD)
  • ACONITUM NAPELLUS (UNII: U0NQ8555JD) (Active Moiety)
  • BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX)
  • BRYONIA CRETICA SUBSP. DIOICA ROOT (UNII: 53UB5FH7CX) (Active Moiety)
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I)
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (Active Moiety)
  • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
  • MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (Active Moiety)
  • CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17)
  • CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (Active Moiety)
  • STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K)
  • STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (Active Moiety)
  • DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV)
  • DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (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 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".