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 ID: 65008-005_5741d20b-37e0-4998-ac55-235d6dea2be9
• NDC: 65008-005
• Product Type: Human Otc Drug
• Proprietary Name: Comfortcaine
• Generic Name: Lidocaine Hcl
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2004-11-12
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: QS Key West Aloe, LLC
• Substance Name: LIDOCAINE HYDROCHLORIDE
• Active Ingredient Strength: 40 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65008-005-04

1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) > 113 g in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65008-005-04 [65008000504]

Comfortcaine GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-03-27

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	40 mg/g

OpenFDA Data

• SPL SET ID: 831b7c11-e437-4e74-808e-c9c1eb8b82f6
• Manufacturer:
  • QS Key West Aloe, LLC
• UNII:
  • V13007Z41A
• RxNorm Concept Unique ID - RxCUI:
  • 1592290
  • 1291672

NDC Crossover Matching brand name "Comfortcaine" or generic name "Lidocaine Hcl"

NDC	Brand Name	Generic Name
68400-994	Comfortcaine	Comfortcaine
65008-005	Comfortcaine	Comfortcaine
41250-093	Aloe Vera Gel	Lidocaine HCl
41167-0568	Aspercreme Lidocaine No-Mess plus Lavender	Lidocaine HCl
24909-701	CBD Clinic - Mild Pain Therapy	Lidocaine HCL
24909-761	CBD Clinic Pain Relief - Level 1	Lidocaine HCL
24909-721	CBD Medic - Odor-Free Serious Relief	Lidocaine HCL
0363-8897	Cooling Gel	Lidocaine HCl
51350-012	CURACAINE	LIDOCAINE HCL
51316-022	CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	Lidocaine HCl
46122-614	GNP Lidocaine	Lidocaine HCl
50804-955	Good Sense Burn Relief Aloe	Lidocaine HCl
47682-320	Green Guard Burn	Lidocaine HCl
47682-330	Green Guard Burn	Lidocaine HCl
51662-1438	LIDOCAINE HCl	LIDOCAINE HCl
51662-1538	LIDOCAINE HCl	LIDOCAINE HCl
44577-704	LidoStat	LIDOCAINE HCL
47682-250	Medi-First Burn	Lidocaine HCl
47682-255	Medi-First Burn	Lidocaine HCl
10742-8386	Mentholatum Lidocaine Heat	Lidocaine HCl
36800-740	Pain Relief	Lidocaine HCl
11822-1116	Pain Relief Roll-on	Lidocaine HCl
50804-774	Pain Relief Roll-on	Lidocaine HCl
15127-002	Select Brand Burn Relief	LIDOCAINE HCL
0869-0005	Sunburn Relief Gel	Lidocaine HCl
0404-9974	Xylocaine	Lidocaine HCl