55714-4857 NDC - TINNITUS (ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA)

Drug Information

  • Product NDC: 55714-4857
  • Proprietary Name: Tinnitus
  • Non Proprietary Name: Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata
  • Active Ingredient(s): 20 [hp_X]/mL ACONITUM NAPELLUS; 20 [hp_X]/mL ALLYLTHIOUREA; 20 [hp_X]/mL ANEMONE PULSATILLA; 20 [hp_X]/mL BARIUM CARBONATE; 20 [hp_X]/mL BARIUM CHLORIDE DIHYDRATE; 20 [hp_X]/mL CAPSICUM; 20 [hp_X]/mL CAUSTICUM; 20 [hp_X]/mL CINCHONA OFFICINALIS BARK; 20 [hp_X]/mL DYSPHANIA AMBROSIOIDES; 20 [hp_X]/mL GOLDENSEAL; 20 [hp_X]/mL GRAPHITE; 20 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 20 [hp_X]/mL NITROGLYCERIN; 20 [hp_X]/mL PHOSPHORUS; 20 [hp_X]/mL POTASSIUM CHLORIDE; 20 [hp_X]/mL POTASSIUM DICHROMATE; 20 [hp_X]/mL QUININE SULFATE; 20 [hp_X]/mL SALICYLIC ACID; 20 [hp_X]/mL TOBACCO LEAF; 20 [hp_X]/mL VIOLA ODORATA
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Antimalarial [EPC]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Nitrate Vasodilator [EPC]; Nitrates [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Potassium Compounds [CS]; Potassium Salt [EPC]; Vasodilation [PE]; Vegetable Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Newton Laboratories, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/31/2024

Package Information

No. Package Code Package Description Billing Unit
155714-4857-130 mL in 1 BOTTLE, GLASS (55714-4857-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC55714-4857The 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 NAMETinnitusThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorataThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE1/31/2024This 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 NAMENewton Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS; ALLYLTHIOUREA; ANEMONE PULSATILLA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATAAn 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 STRENGTH20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 
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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS] 

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This page was last updated on: 11/21/2025

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