NDC 10237-746

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; Benzalkonium Chloride.

Product ID10237-746_62aa9807-d15c-45c8-a8c3-50a08d96123c
NDC10237-746
Product TypeHuman Otc Drug
Proprietary NameOrajel Instant Pain Relief Maximum
Generic NameBenzocaine 20%, Benzalkonium Chloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-12-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch Dwight Co., Inc.
Substance NameBENZOCAINE; BENZALKONIUM CHLORIDE
Active Ingredient Strength200 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-746-12

1 TUBE in 1 PACKAGE (10237-746-12) > 3.5 g in 1 TUBE
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-746-42 [10237074642]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01
Marketing End Date2019-12-20

NDC 10237-746-12 [10237074612]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01
Marketing End Date2019-12-20

NDC 10237-746-25 [10237074625]

Orajel Instant Pain Relief Maximum GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01
Marketing End Date2019-12-20

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:c8c6150c-5dfa-4cd5-8743-8a18d38b5a99
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1483224
  • 1483229
  • 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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