NDC 53045-125

Opahl

Benzocaine

Opahl is a Dental; Oral; Topical Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Dharma Research, Inc.. The primary component is Benzocaine.

Product ID53045-125_c2ad7bd9-78c9-40d9-9d3f-8e3c56de6036
NDC53045-125
Product TypeHuman Prescription Drug
Proprietary NameOpahl
Generic NameBenzocaine
Dosage FormSpray, Metered
Route of AdministrationDENTAL; ORAL; TOPICAL
Marketing Start Date2013-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameDharma Research, inc.
Substance NameBENZOCAINE
Active Ingredient Strength12 g/60g
Pharm ClassesStandardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53045-125-60

60 g in 1 BOTTLE (53045-125-60)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53045-125-60 [53045012560]

Opahl SPRAY, METERED
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE12 g/60g

OpenFDA Data

SPL SET ID:2b4a6b21-396a-4b07-b1b9-751643cb5821
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1435490
  • Pharmacological Class

    • Standardized Chemical Allergen [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Allergens [CS]

    NDC Crossover Matching brand name "Opahl" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    53045-125OpahlOpahl
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

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