NDC 81417-121

Oral Pain Relief Gel

Benzocaine 20%

Oral Pain Relief Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sled Distribution, Llc. The primary component is Benzocaine.

Product ID81417-121_8a1fca56-0c73-4509-80fe-4dea3c764c52
NDC81417-121
Product TypeHuman Otc Drug
Proprietary NameOral Pain Relief Gel
Generic NameBenzocaine 20%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2022-03-25
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart356
Labeler NameSled Distribution, LLC
Substance NameBENZOCAINE
Active Ingredient Strength200 mg/g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81417-121-01

1 BAG in 1 PACKAGE (81417-121-01) > .75 g in 1 BAG
Marketing Start Date2022-03-25
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Oral Pain Relief Gel" or generic name "Benzocaine 20%"

NDCBrand NameGeneric Name
81417-001Oral Pain Relief GelBenzocaine 20%
81417-121Oral Pain Relief GelBenzocaine 20%
73635-7101Anesgerm LA MUELABenzocaine 20%
37205-607Leader Oral Pain ReliefBenzocaine 20%
68599-8247McKesson Orasol GelBenzocaine 20%
10237-753Orajel Instant Pain ReliefBenzocaine 20%
10237-755Orajel Instant Pain ReliefBenzocaine 20%

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