84260-010 NDC - EXTENDED TOPICAL SPRAYS FOR MEN (CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE)

Drug Information

  • Product NDC: 84260-010
  • Proprietary Name: Extended topical sprays for men
  • Non Proprietary Name: CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE
  • Active Ingredient(s): 2.8 g/100mL CLOVE; 1.2 g/100mL CNIDIUM MONNIERI WHOLE; 9.5 g/100mL CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE; .6 g/100mL ZANTHOXYLUM BUNGEANUM FRUIT
  • Administration Route(s): TOPICAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Guangzhou Lvying Biotechnology Co., Ltd
Product Type: HUMAN OTC DRUG
FDA Application Number: 505G(a)(3)
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:3/13/2025

Package Information

No. Package Code Package Description Billing Unit
184260-010-011 mL in 1 BOTTLE (84260-010-01)
284260-010-025 mL in 1 BOTTLE (84260-010-02)
384260-010-0310 mL in 1 BOTTLE (84260-010-03)

NDC Record

Field Name Field Value Definition
PRODUCT NDC84260-010The 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 NAMEExtended topical sprays for menThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLEThe 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 NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/13/2025This 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 NUMBER505G(a)(3)This 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 NAMEGuangzhou Lvying Biotechnology Co., LtdName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECLOVE; CNIDIUM MONNIERI WHOLE; CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE; ZANTHOXYLUM BUNGEANUM FRUITAn 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 STRENGTH2.8; 1.2; 9.5; .6 
ACTIVE INGRED UNITg/100mL; g/100mL; g/100mL; g/100mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] 

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

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

Previous Code
Next Code