46414-8888 NDC - BENZOIN

Drug Information

Product NDC: 46414-8888

Proprietary Name: Benzoin

Non Proprietary Name: Benzoin

Active Ingredient(s):
  • .12 g/.6mL ALOE;
  • .6 g/.6mL BENZOIN, (+/-)-;
  • .48 g/.6mL LIQUIDAMBAR STYRACIFLUA RESIN;
  • .24 g/.6mL TOLU BALSAM


Administration Route(s): TOPICAL

Dosage Form(s): SWAB

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Increased Histamine Release [PE];
  • Standardized Chemical Allergen [EPC]

Labeler Information

Labeler Name: James Alexander Corporation
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:10/25/1976
End Marketing Date:2/28/2025

Package Information

No. Package Code Package Description Billing Unit
146414-8888-260 mL in 1 BOX (46414-8888-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC46414-8888The 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 NAMEBenzoinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzoinThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESWABThe 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 DATE10/25/1976This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE2/28/2025This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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 NAMEJames Alexander CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALOE; BENZOIN, (+/-)-; LIQUIDAMBAR STYRACIFLUA RESIN; TOLU BALSAMAn 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; .48; .24 
ACTIVE INGRED UNITg/.6mL; g/.6mL; g/.6mL; g/.6mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] 

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This page was last updated on: 2/1/2023