36800-805 NDC - TOPCARE HEALTH COLD REMEDY (ZINCUM GLUCONICUM)

Drug Information

Product NDC: 36800-805

Proprietary Name: TopCare Health Cold Remedy

Non Proprietary Name: Zincum Gluconicum

Active Ingredient(s):
  • 1 [hp_X]/1 ZINC GLUCONATE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Copper Absorption Inhibitor [EPC];
  • Decreased Copper Ion Absorption [PE]

Labeler Information

Labeler Name: TOPCO ASSOCIATES LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:4/17/2019

Package Information

No. Package Code Package Description Billing Unit
136800-805-2525 TABLET in 1 BOTTLE, PLASTIC (36800-805-25)

NDC Record

Field Name Field Value Definition
PRODUCT NDC36800-805The 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 NAMETopCare Health Cold RemedyThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXCherry FlavorA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEZincum GluconicumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/17/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMETOPCO ASSOCIATES LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEZINC GLUCONATEAn 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 STRENGTH1 
ACTIVE INGRED UNIT[hp_X]/1 
PHARM CLASSESCopper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] 

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This page was last updated on: 2/1/2023