NDC 10237-762

Orajel Instant Pain Relief Maximum

Benzocaine 20%, Benzalkonium Chloride

Orajel Instant Pain Relief Maximum 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; Menthol.

Product ID10237-762_505a73f5-fc6e-738c-e054-00144ff88e88
NDC10237-762
Product TypeHuman Otc Drug
Proprietary NameOrajel Instant Pain Relief Maximum
Generic NameBenzocaine 20%, Benzalkonium Chloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-07-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch Dwight Co., Inc.
Substance NameBENZOCAINE; MENTHOL
Active Ingredient Strength200 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-762-12

1 TUBE in 1 PACKAGE (10237-762-12) > 3.5 g in 1 TUBE
Marketing Start Date2016-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-762-12 [10237076212]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-27
Marketing End Date2019-12-31

NDC 10237-762-25 [10237076225]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-27
Marketing End Date2019-12-31

NDC 10237-762-42 [10237076242]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-27
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:38a00691-7290-08a7-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1802557
  • 1802555
  • NDC Crossover Matching brand name "Orajel Instant Pain Relief Maximum" or generic name "Benzocaine 20%, Benzalkonium Chloride"

    NDCBrand NameGeneric Name
    10237-755Orajel Instant Pain Relief MAXIMUMOrajel Instant Pain Relief MAXIMUM
    10237-746Orajel Instant Pain ReliefBenzocaine 20%, Benzalkonium Chloride
    10237-762Orajel Instant Pain ReliefBenzocaine 20%, Benzalkonium Chloride

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