53045-125 NDC - OPAHL (BENZOCAINE)

Drug Information

Product NDC: 53045-125

Proprietary Name: Opahl

Non Proprietary Name: Benzocaine

Active Ingredient(s):
  • 12 g/60g BENZOCAINE


Administration Route(s): DENTAL; ORAL; TOPICAL

Dosage Form(s): SPRAY, METERED

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

Labeler Information

Labeler Name: Dharma Research, inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:1/1/2013

Package Information

No. Package Code Package Description Billing Unit
153045-125-6060 g in 1 BOTTLE (53045-125-60)

NDC Record

Field Name Field Value Definition
PRODUCT NDC53045-125The 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 NAMEOpahlThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzocaineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAY, METEREDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTAL; ORAL; TOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2013This 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 NAMEDharma Research, inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZOCAINEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH12 
ACTIVE INGRED UNITg/60g 
PHARM CLASSESStandardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS] 

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This page was last updated on: 8/16/2019