NDC 10237-753

Orajel Instant Pain Relief SEVERE

Benzocaine 20%

Orajel Instant Pain Relief SEVERE is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine.

Product ID10237-753_30928a98-5e42-446a-8bbd-f97a46560711
NDC10237-753
Product TypeHuman Otc Drug
Proprietary NameOrajel Instant Pain Relief SEVERE
Generic NameBenzocaine 20%
Dosage FormLiquid
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
Active Ingredient Strength200 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-753-45

1 BOTTLE, GLASS in 1 CARTON (10237-753-45) > 13.3 g in 1 BOTTLE, GLASS
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-753-45 [10237075345]

Orajel Instant Pain Relief SEVERE LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:707d27da-731c-4726-9c77-63fcc071d09d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308657
  • 1045335
  • NDC Crossover Matching brand name "Orajel Instant Pain Relief SEVERE" or generic name "Benzocaine 20%"

    NDCBrand NameGeneric Name
    10237-747Orajel Instant Pain Relief SevereOrajel Instant Pain Relief Severe
    10237-752Orajel Instant Pain Relief SevereOrajel Instant Pain Relief Severe
    73635-7101Anesgerm LA MUELABenzocaine 20%
    10237-766Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
    10237-768Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
    10237-769Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
    10237-770Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
    37205-607Leader Oral Pain ReliefBenzocaine 20%
    68599-8247McKesson Orasol GelBenzocaine 20%
    10237-753Orajel Instant Pain ReliefBenzocaine 20%
    10237-755Orajel Instant Pain ReliefBenzocaine 20%
    81417-001Oral Pain Relief GelBenzocaine 20%
    81417-121Oral Pain Relief GelBenzocaine 20%

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