NDC 65008-005

Comfortcaine

Lidocaine Hcl

Comfortcaine is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Qs Key West Aloe, Llc. The primary component is Lidocaine Hydrochloride.

Product ID65008-005_5741d20b-37e0-4998-ac55-235d6dea2be9
NDC65008-005
Product TypeHuman Otc Drug
Proprietary NameComfortcaine
Generic NameLidocaine Hcl
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2004-11-12
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameQS Key West Aloe, LLC
Substance NameLIDOCAINE HYDROCHLORIDE
Active Ingredient Strength40 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65008-005-04

1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) > 113 g in 1 BOTTLE, PLASTIC
Marketing Start Date2017-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65008-005-04 [65008000504]

Comfortcaine GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-27

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/g

OpenFDA Data

SPL SET ID:831b7c11-e437-4e74-808e-c9c1eb8b82f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1592290
  • 1291672