80069-013 NDC - BLUE GEL ANESTHETIC (LIDOCAINE HCL, TETRACAINE HCL, RACEPINEPHRINE HCL)

Drug Information

Product NDC: 80069-013

Proprietary Name: Blue Gel Anesthetic

Non Proprietary Name: Lidocaine HCl, Tetracaine HCl, Racepinephrine HCl

Active Ingredient(s):
  • 50 mg/g LIDOCAINE HYDROCHLORIDE;
  • .1 mg/g RACEPINEPHRINE HYDROCHLORIDE;
  • 10 mg/g TETRACAINE HYDROCHLORIDE


Administration Route(s): TOPICAL

Dosage Form(s): GEL

Pharmacy Class(es):
  • Amide Local Anesthetic [EPC];
  • Amides [CS];
  • Antiarrhythmic [EPC];
  • Ester Local Anesthetic [EPC];
  • Esters [CS];
  • Local Anesthesia [PE];
  • Local Anesthesia [PE]

Labeler Information

Labeler Name: Dermal Source, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:6/7/2022

Package Information

No. Package Code Package Description Billing Unit
180069-013-0128.3495 g in 1 BOTTLE, PLASTIC (80069-013-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC80069-013The 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 NAMEBlue Gel AnestheticThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELidocaine HCl, Tetracaine HCl, Racepinephrine HClThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGELThe 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 DATE6/7/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMEDermal Source, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELIDOCAINE HYDROCHLORIDE; RACEPINEPHRINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDEAn 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 STRENGTH50; .1; 10 
ACTIVE INGRED UNITmg/g; mg/g; mg/g 
PHARM CLASSESAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE] 

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