84859-114 NDC - BEAUTE (KOJIC ACID)

Drug Information

  • Product NDC: 84859-114
  • Proprietary Name: Beaute
  • Non Proprietary Name: Kojic Acid
  • Active Ingredient(s): .24 g/30g ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%); .09 g/30g ALLANTOIN; .75 g/30g CAPRYLIC/CAPRIC TRIGLYCERIDE; .3 g/30g CETYL ALCOHOL; .6 g/30g CYCLOMETHICONE; .6 g/30g DIETHYLENE GLYCOL DISTEARATE; .6 g/30g DIMETHICONE; .03 g/30g EDTA; .6 g/30g KOJIC DIPALMITATE; .3 g/30g TRIETHANOLAMINE; .3 g/30g XYLITYLGLUCOSIDE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM
  • Pharmacy Class(es): Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Decreased Coagulation Factor Activity [PE]; Lead Chelating Activity [MoA]; Lead Chelator [EPC]; Skin Barrier Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: Novamed Healthcare Private Limited
Product Type: HUMAN OTC DRUG
FDA Application Number: M016
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:1/28/2025

Package Information

No. Package Code Package Description Billing Unit
184859-114-011 TUBE in 1 BOX (84859-114-01) / 30 g in 1 TUBE (84859-114-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC84859-114The 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 NAMEBeauteThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEKojic AcidThe 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 DATE1/28/2025This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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.
APPLICATION NUMBERM016This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMENovamed Healthcare Private LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%); ALLANTOIN; CAPRYLIC/CAPRIC TRIGLYCERIDE; CETYL ALCOHOL; CYCLOMETHICONE; DIETHYLENE GLYCOL DISTEARATE; DIMETHICONE; EDTA; KOJIC DIPALMITATE; TRIETHANOLAMINE; XYLITYLGLUCOSIDEAn 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.24; .09; .75; .3; .6; .6; .6; .03; .6; .3; .3 
ACTIVE INGRED UNITg/30g; g/30g; g/30g; g/30g; g/30g; g/30g; g/30g; g/30g; g/30g; g/30g; g/30g 
PHARM CLASSESAnti-coagulant [EPC], Calcium Chelating Activity [MoA], Decreased Coagulation Factor Activity [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC], Skin Barrier Activity [PE] 

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

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