NDC 68987-004

PureLife Topical Anesthetic

Benzocaine

PureLife Topical Anesthetic is a Dental Gel in the Human Otc Drug category. It is labeled and distributed by Purelife Dental. The primary component is Benzocaine.

Product ID68987-004_d5942fdf-570d-12d8-e053-2995a90a636b
NDC68987-004
Product TypeHuman Otc Drug
Proprietary NamePureLife Topical Anesthetic
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationDENTAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NamePureLife Dental
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68987-004-30

30 g in 1 JAR (68987-004-30)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68987-004-30 [68987000430]

PureLife Topical Anesthetic GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:ea8e5036-8c30-4527-9f0b-5c474bb0debd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238910

    • NDC Crossover Matching brand name "PureLife Topical Anesthetic" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    68987-002PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-001PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-003PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-007PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-004PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-006PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-008PureLife Topical AnestheticPureLife Topical Anesthetic
    68987-005PureLife Topical AnestheticPureLife Topical Anesthetic
    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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