comfortcaine

Generic: lidocaine hcl

Labeler: qs key west aloe, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name comfortcaine
Generic Name lidocaine hcl
Labeler qs key west aloe, llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

lidocaine hydrochloride 40 mg/g

Manufacturer
QS Key West Aloe, LLC

Identifiers & Regulatory

Product NDC 65008-005
Product ID 65008-005_4354972c-d9c9-cd90-e063-6294a90ad4c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2004-11-12

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65008005
Hyphenated Format 65008-005

Supplemental Identifiers

RxCUI
1291672 1592290
UNII
V13007Z41A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name comfortcaine (source: ndc)
Generic Name lidocaine hcl (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) / 113 g in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

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

Ingredients (1)

lidocaine hydrochloride (40 mg/g)

Linked Drug Pages (1)

Comfortcaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4354972c-d9c9-cd90-e063-6294a90ad4c5", "openfda": {"unii": ["V13007Z41A"], "rxcui": ["1291672", "1592290"], "spl_set_id": ["831b7c11-e437-4e74-808e-c9c1eb8b82f6"], "manufacturer_name": ["QS Key West Aloe, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04)  / 113 g in 1 BOTTLE, PLASTIC", "package_ndc": "65008-005-04", "marketing_start_date": "20230623"}], "brand_name": "Comfortcaine", "product_id": "65008-005_4354972c-d9c9-cd90-e063-6294a90ad4c5", "dosage_form": "GEL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "65008-005", "generic_name": "Lidocaine HCL", "labeler_name": "QS Key West Aloe, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Comfortcaine", "active_ingredients": [{"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20041112", "listing_expiration_date": "20261231"}