58264-0125 NDC - D-119 (PLANTAGO MAJOR, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA CHAMOMILLA, SEPIA OFFICINALIS JUICE, ARNICA MONTANA, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, SPIGELIA ANTHELMIA, IRON, BARIUM CARBONATE, VERATRUM ALBUM ROOT, CALCIUM FLUORIDE, ANTIPYRINE, AND BISMUTH SUBNITRATE)

Drug Information

Product NDC: 58264-0125
Proprietary Name: D-119
Non Proprietary Name: Plantago major, Delphinium staphisagria seed, Matricaria chamomilla, Sepia officinalis juice, Arnica montana, Hypericum perforatum, Strychnos nux-vomica seed, Spigelia anthelmia, Iron, Barium carbonate, Veratrum album root, Calcium fluoride, Antipyrine, and Bismuth subnitrate
Active Ingredient(s): 12 [hp_X]/mL ANTIPYRINE; 6 [hp_X]/mL ARNICA MONTANA; 8 [hp_X]/mL BARIUM CARBONATE; 8 [hp_X]/mL BISMUTH SUBNITRATE; 8 [hp_X]/mL CALCIUM FLUORIDE; 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED; 6 [hp_X]/mL HYPERICUM PERFORATUM; 8 [hp_X]/mL IRON; 30 [hp_X]/mL MATRICARIA CHAMOMILLA; 6 [hp_X]/mL PLANTAGO MAJOR; 6 [hp_X]/mL SEPIA OFFICINALIS JUICE; 6 [hp_X]/mL SPIGELIA ANTHELMIA; 4 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 6 [hp_X]/mL VERATRUM ALBUM ROOT
Administration Route(s): SUBLINGUAL
Dosage Form(s): SOLUTION
Pharmacy Class(es): Allergens [CS]; Bismuth [CS]; Bismuth [EPC]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	DNA Labs, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	1/1/1990

Package Information

No.	Package Code	Package Description	Billing Unit
1	58264-0125-1	29.57 mL in 1 BOTTLE, GLASS (58264-0125-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	58264-0125	The 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 NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	D-119	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Plantago major, Delphinium staphisagria seed, Matricaria chamomilla, Sepia officinalis juice, Arnica montana, Hypericum perforatum, Strychnos nux-vomica seed, Spigelia anthelmia, Iron, Barium carbonate, Veratrum album root, Calcium fluoride, Antipyrine, and Bismuth subnitrate	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	SUBLINGUAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	1/1/1990	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	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.
LABELER NAME	DNA Labs, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ANTIPYRINE; ARNICA MONTANA; BARIUM CARBONATE; BISMUTH SUBNITRATE; CALCIUM FLUORIDE; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; IRON; MATRICARIA CHAMOMILLA; PLANTAGO MAJOR; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT	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.
ACTIVE NUMERATOR STRENGTH	12; 6; 8; 8; 8; 12; 6; 8; 30; 6; 6; 6; 4; 6
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Allergens [CS], Bismuth [CS], Bismuth [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]

Drug Information

Labeler Information

Package Information

NDC Record

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