61500-5547 NDC - TOPRICIN (AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFUR)

Drug Information

  • Product NDC: 61500-5547
  • Proprietary Name: Topricin
  • Non Proprietary Name: aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur
  • Active Ingredient(s): 6 [hp_X]/227g AESCULUS HIPPOCASTANUM FLOWER; 6 [hp_X]/227g ARNICA MONTANA; 6 [hp_X]/227g ATROPA BELLADONNA; 4 [hp_X]/227g CALENDULA OFFICINALIS FLOWERING TOP; 8 [hp_X]/227g CROTALUS HORRIDUS HORRIDUS VENOM; 4 [hp_X]/227g ECHINACEA ANGUSTIFOLIA; 6 [hp_X]/227g GRAPHITE; 8 [hp_X]/227g HELODERMA HORRIDUM VENOM; 8 [hp_X]/227g LACHESIS MUTA VENOM; 8 [hp_X]/227g NAJA NAJA VENOM; 9 [hp_X]/227g PHOSPHORUS; 6 [hp_X]/227g RUTA GRAVEOLENS FLOWERING TOP; 8 [hp_X]/227g SULFUR; 8 [hp_X]/227g TOXICODENDRON PUBESCENS LEAF
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM

Labeler Information

Field Name Field Value
Labeler Name: Topical BioMedics, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/18/2016
End Marketing Date:4/1/2026

Package Information

No. Package Code Package Description Billing Unit
161500-5547-02 g in 1 PACKET (61500-5547-0)
261500-5547-121 g in 1 TUBE (61500-5547-1)
361500-5547-257 g in 1 TUBE (61500-5547-2)
461500-5547-4113 g in 1 JAR (61500-5547-4)
561500-5547-8454 g in 1 BOTTLE (61500-5547-8)
661500-5547-9227 g in 1 BOTTLE (61500-5547-9)

NDC Record

Field Name Field Value Definition
PRODUCT NDC61500-5547The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMETopricinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEaesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfurThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/18/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE4/1/2026This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMETopical BioMedics, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAFAn 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.
ACTIVE NUMERATOR STRENGTH6; 6; 6; 4; 8; 4; 6; 8; 8; 8; 9; 6; 8; 8 
ACTIVE INGRED UNIT[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g 

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This page was last updated on: 4/25/2025

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