NDC 10237-792

Orajel Gum Pain 3X Medicated

Benzocaine, Menthol, Zinc Chloride

Orajel Gum Pain 3X Medicated is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine; Zinc Chloride; Menthol.

Product ID10237-792_9a1632ad-2b48-5653-e053-2995a90ae0d9
NDC10237-792
Product TypeHuman Otc Drug
Proprietary NameOrajel Gum Pain 3X Medicated
Generic NameBenzocaine, Menthol, Zinc Chloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-12-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameChurch & Dwight Co., Inc.
Substance NameBENZOCAINE; ZINC CHLORIDE; MENTHOL
Active Ingredient Strength200 mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10237-792-12

1 TUBE in 1 PACKAGE (10237-792-12) > 3.5 g in 1 TUBE
Marketing Start Date2019-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-792-12 [10237079212]

Orajel Gum Pain 3X Medicated GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-12-17

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:9a1632ad-2b47-5653-e053-2995a90ae0d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2266761
  • NDC Crossover Matching brand name "Orajel Gum Pain 3X Medicated" or generic name "Benzocaine, Menthol, Zinc Chloride"

    NDCBrand NameGeneric Name
    10237-791Orajel Gum Pain 3X MedicatedBenzocaine, Menthol, Zinc chloride
    10237-792Orajel Gum Pain 3X Medicatedbenzocaine, menthol, zinc chloride
    69842-331CVS Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    69842-334CVS Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    58552-135Giltuss BucalsepBenzocaine, Menthol, Zinc chloride
    41250-552Meijer Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    10237-783Orajel 3X Medicated For All Mouth SoresBenzocaine, Menthol, Zinc Chloride
    10237-723Orajel 3X Medicated for Denture PainBenzocaine, Menthol, Zinc Chloride
    10237-790Orajel 3X Medicated For Toothache and GumBenzocaine, Menthol, Zinc chloride
    10237-772Orajel Denture Pain ReliefBenzocaine, Menthol, Zinc Chloride
    10237-778Orajel Denture Pain ReliefBenzocaine, Menthol, Zinc Chloride
    11822-6037Rite Aid Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    11822-6038Rite Aid Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    0363-5350Walgreens Instant Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    0363-5351Walgreens Instant Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride

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