FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct65008-005EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage65008-00565008-005-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1291672Internal RxNorm lookup
1592290Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
831b7c11-e437-4e74-808e-c9c1eb8b82f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65008-005-04Comfortcaine113 g in 1 BOTTLE, PLASTICGEL1137
65008-005-04Comfortcaine1 in 1 CARTONGEL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65008-005COMFORTCAINE (LIDOCAINE HCL) GEL [QS KEY WEST ALOE, LLC]5Current NDC, Legacy NDC, 2 package rows20241124_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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
application number: M017
DRAWYUM Pain Relief Gel-PatchLIDOCAINE 4% PAIN RELIEF GEL-PATCHJiangxi Yudexi Pharmaceutical Co., LTD497e6e18-ba46-0001-e063-6294a90af0262026-06-12WarningsExact identifier
application number: M017
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
application number: M017
MG PLUS MENTHOLMENTHOLRENU LABORATORIES, LLC53737365-b985-3800-e063-6294a90a37f22026-06-11WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsExact identifier
application number: M017
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a47f1ed-d8cf-3b0b-e063-6394a90a932a2026-06-11WarningsExact identifier
application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsExact identifier
application number: M017
Warm Patch Tong Gu Huo Luo GaoPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory6906c4a0-1557-45e3-b915-80e4dd652ee72026-06-10WarningsExact identifier
application number: M017
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
application number: M017
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
application number: M017
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin cream for sensitive skinCAPSAICIN 0.1%Easment LLC537e0106-9e1c-66b8-e063-6294a90ac5382026-06-05WarningsExact identifier
application number: M017
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
application number: M017
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
application number: M017
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
application number: M017
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1592290Comfortcaine 4 % Topical GelPSN831b7c11-e437-4e74-808e-c9c1eb8b82f67
1291672lidocaine 4 % Topical GelPSN831b7c11-e437-4e74-808e-c9c1eb8b82f67
1592290lidocaine 0.04 MG/MG Topical Gel [Comfortcaine]SBD831b7c11-e437-4e74-808e-c9c1eb8b82f67
1291672lidocaine 0.04 MG/MG Topical GelSCD831b7c11-e437-4e74-808e-c9c1eb8b82f67
1592290Comfortcaine 0.04 MG/MG Topical GelSY831b7c11-e437-4e74-808e-c9c1eb8b82f67
1592290Comfortcaine 4 % Topical GelSY831b7c11-e437-4e74-808e-c9c1eb8b82f67
1291672lidocaine 4 % Topical GelSY831b7c11-e437-4e74-808e-c9c1eb8b82f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65008-005-04650080005041 BOTTLE, PLASTIC in 1 CARTON (65008-005-04) / 113 g in 1 BOTTLE, PLASTIC2023-06-230000-00-00NoNoCurrent