11344-234 NDC - GERM-X (ALCOHOL)

Drug Information

Product NDC: 11344-234

Proprietary Name: Germ-X

Non Proprietary Name: Alcohol

Active Ingredient(s):
  • 63 mg/mL ALCOHOL


Administration Route(s): TOPICAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Vi Jon, Inc
Product Type: HUMAN OTC DRUG
FDA Application Number: part333A
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:7/12/1999

Package Information

No. Package Code Package Description Billing Unit
111344-234-10295 mL in 1 BOTTLE, PUMP (11344-234-10)
211344-234-1659 mL in 1 BOTTLE, PLASTIC (11344-234-16)
311344-234-1873 mL in 1 BOTTLE, PLASTIC (11344-234-18)
411344-234-2044 mL in 1 BOTTLE, PLASTIC (11344-234-20)
511344-234-2189 mL in 1 BOTTLE, PLASTIC (11344-234-21)
611344-234-34237 mL in 1 BOTTLE, PUMP (11344-234-34)
711344-234-40354 mL in 1 BOTTLE, PUMP (11344-234-40)
811344-234-42828 mL in 1 BOTTLE, PUMP (11344-234-42)
911344-234-49443 mL in 1 BOTTLE, PUMP (11344-234-49)
1011344-234-571182 mL in 1 BOTTLE, PUMP (11344-234-57)
1111344-234-63199 mL in 1 BOTTLE, PLASTIC (11344-234-63)
1211344-234-681656 mL in 1 BOTTLE, PLASTIC (11344-234-68)
1311344-234-83887 mL in 1 BOTTLE, PLASTIC (11344-234-83)
1411344-234-881999 mL in 1 BOTTLE, PUMP (11344-234-88)

NDC Record

Field Name Field Value Definition
PRODUCT NDC11344-234The 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 NAMEGerm-XThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAlcoholThe 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 DATE7/12/1999This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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 NUMBERpart333AThis 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 NAMEVi Jon, IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALCOHOLThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH63 
ACTIVE INGRED UNITmg/mL 

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This page was last updated on: 10/4/2019