84509-035 NDC - AOAO KOJIC ACID WHITENING LIGHTENER (OLEA EUROPAEA (OLIVE) FRUIT OIL,KOJIC ACID,COCOS NUCIFERA (COCONUT) OIL,SUCROSE,ALOE BARBADENSIS LEAF EXTRACT,TOCOPHEROL)

Drug Information

  • Product NDC: 84509-035
  • Proprietary Name: AOAO Kojic Acid Whitening Lightener
  • Non Proprietary Name: Olea Europaea (Olive) Fruit Oil,Kojic Acid,Cocos Nucifera (Coconut) Oil,Sucrose,Aloe Barbadensis Leaf Extract,Tocopherol
  • Active Ingredient(s): 1600 mg/80g ALOE BARBADENSIS LEAF EXTRACT; 2400 mg/80g COCOS NUCIFERA (COCONUT) OIL; 3200 mg/80g KOJIC ACID; 4800 mg/80g OLEA EUROPAEA (OLIVE) FRUIT OIL; 1600 mg/80g SUCROSE; 1600 mg/80g TOCOPHEROL
  • Administration Route(s): TOPICAL
  • Dosage Form(s): SOAP
  • Pharmacy Class(es): Lipid Emulsion [EPC]; Lipids [CS]

Labeler Information

Field Name Field Value
Labeler Name: Guangdong Junhui Biotechnology Co., LTD
Product Type: HUMAN OTC DRUG
FDA Application Number: M016
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:10/29/2024

Package Information

No. Package Code Package Description Billing Unit
184509-035-0180 g in 1 BOTTLE (84509-035-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC84509-035The 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 NAMEAOAO Kojic Acid Whitening LightenerThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEOlea Europaea (Olive) Fruit Oil,Kojic Acid,Cocos Nucifera (Coconut) Oil,Sucrose,Aloe Barbadensis Leaf Extract,TocopherolThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOAPThe 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 DATE10/29/2024This 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 NAMEGuangdong Junhui Biotechnology Co., LTDName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALOE BARBADENSIS LEAF EXTRACT; COCOS NUCIFERA (COCONUT) OIL; KOJIC ACID; OLEA EUROPAEA (OLIVE) FRUIT OIL; SUCROSE; TOCOPHEROLAn 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 STRENGTH1600; 2400; 3200; 4800; 1600; 1600 
ACTIVE INGRED UNITmg/80g; mg/80g; mg/80g; mg/80g; mg/80g; mg/80g 
PHARM CLASSESLipid Emulsion [EPC], Lipids [CS] 

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

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