Home NDC 65008-005 Comfortcaine
Product NDC 65008-005
11-digit product format 650080005
Labeler code 65008
Product ID 65008-005_4354972c-d9c9-cd90-e063-6294a90ad4c5
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCL
Dosage form GEL
Route TOPICAL
Labeler QS Key West Aloe, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-11-12
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 65008-005 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65008-005 65008-005-04 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Comfortcaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1291672 Internal RxNorm lookup 1592290 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65008-005-04 Comfortcaine 113 g in 1 BOTTLE, PLASTIC GEL 113 7 65008-005-04 Comfortcaine 1 in 1 CARTON GEL 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65008-005 COMFORTCAINE (LIDOCAINE HCL) GEL [QS KEY WEST ALOE, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241124_831b7c11-e437-4e74-808e-c9c1eb8b82f6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 156 · 3,115 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65008-005-04 65008000504 1 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) / 113 g in 1 BOTTLE, PLASTIC 2023-06-23 0000-00-00 No No Current