53499-5182 NDC - SAMBUCUS COLD FLU RELIEF ELDERBERRY (PELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC)

Drug Information

  • Product NDC: 53499-5182
  • Proprietary Name: Sambucus Cold Flu Relief Elderberry
  • Non Proprietary Name: Pelargonium Sidoides Root, Aconitum Napellus, Eucalyptus Globulus Leaf, Sambucus Nigra Flowering Top, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Phosphorus, Ipecac
  • Active Ingredient(s): 4 [hp_X]/5.3g ACONITUM NAPELLUS; 4 [hp_X]/5.3g BRYONIA ALBA ROOT; 2 [hp_X]/5.3g EUCALYPTUS GLOBULUS LEAF; 6 [hp_X]/5.3g EUPATORIUM PERFOLIATUM FLOWERING TOP; 4 [hp_X]/5.3g GELSEMIUM SEMPERVIRENS ROOT; 3 [hp_X]/5.3g IPECAC; 1 [hp_X]/5.3g PELARGONIUM SIDOIDES ROOT; 6 [hp_X]/5.3g PHOSPHORUS; 3 [hp_X]/5.3g SAMBUCUS NIGRA FLOWERING TOP
  • Administration Route(s): ORAL
  • Dosage Form(s): POWDER

Labeler Information

Field Name Field Value
Labeler Name: Schwabe North America, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/10/2025

Package Information

No. Package Code Package Description Billing Unit
153499-5182-010 PACKET in 1 CARTON (53499-5182-0) / 5.3 g in 1 PACKET

NDC Record

Field Name Field Value Definition
PRODUCT NDC53499-5182The 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 NAMESambucus Cold Flu Relief ElderberryThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPelargonium Sidoides Root, Aconitum Napellus, Eucalyptus Globulus Leaf, Sambucus Nigra Flowering Top, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Phosphorus, IpecacThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe 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 DATE1/10/2025This 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 NAMESchwabe North America, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOPAn 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 STRENGTH4; 4; 2; 6; 4; 3; 1; 6; 3 
ACTIVE INGRED UNIT[hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g; [hp_X]/5.3g 

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This page was last updated on: 2/5/2026

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