53225-1025 NDC - LIDOTHOL (LIDOCAINE, MENTHOL)

Drug Information

Product NDC: 53225-1025

Proprietary Name: LIDOTHOL

Non Proprietary Name: LIDOCAINE, MENTHOL

Active Ingredient(s):
  • 4.5 g/1 LIDOCAINE;
  • 5 g/1 MENTHOL


Administration Route(s): TOPICAL

Dosage Form(s): PATCH

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

Labeler Information

Labeler Name: Terrain Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:6/16/2015

Package Information

No. Package Code Package Description Billing Unit
153225-1025-115 PATCH in 1 BOX (53225-1025-1) / 1 PATCH in 1 PATCHEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC53225-1025The 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 PRESCRIPTION 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 NAMELIDOTHOLThe 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, MENTHOLThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPATCHThe 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 DATE6/16/2015This 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 NAMETerrain PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELIDOCAINE; MENTHOLAn 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 STRENGTH4.5; 5 
ACTIVE INGRED UNITg/1; g/1 
PHARM CLASSESAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] 

Download Record

Download this NDC record in Text format: Export

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

Download this NDC record in XML format: Export

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