NDC 10237-745

Orajel Instant Pain Relief Regular

Benzocaine 10%

Orajel Instant Pain Relief Regular 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.

Product ID10237-745_3fec0c2f-12a8-4e59-85f2-561838078fa2
NDC10237-745
Product TypeHuman Otc Drug
Proprietary NameOrajel Instant Pain Relief Regular
Generic NameBenzocaine 10%
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
Active Ingredient Strength100 mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-745-25

1 TUBE in 1 PACKAGE (10237-745-25) > 2.5 g in 1 TUBE
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-745-25 [10237074525]

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

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE100 mg/g

OpenFDA Data

SPL SET ID:5e81d2e2-cfc6-4de8-a441-fbb994e1205b
Manufacturer
UNII

NDC Crossover Matching brand name "Orajel Instant Pain Relief Regular" or generic name "Benzocaine 10%"

NDCBrand NameGeneric Name
77375-005Chigger ReliefBenzocaine 10%
76168-607Family wellnessBenzocaine 10%
10237-745Orajel Instant Pain ReliefBenzocaine 10%
72839-699REALTREEBenzocaine 10%
72839-069Warrior Chiggerex ReliefBenzocaine 10%

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.