FDA.reportPublic FDA data

Arte Maximum strength Numbing Cream

Product NDC
54723-024
11-digit product format
547230024
Labeler code
54723
Product ID
54723-024_436c23a5-7aac-c334-e063-6394a90ad47e
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-07
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100g
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

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
Arte Maximum strength Numbing Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e612a256-3f44-46db-bb6a-e550c2216fdcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-024-01Arte Maximum strength Numbing Cream30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-024ARTE MAXIMUM STRENGTH NUMBING CREAM (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20250215_e612a256-3f44-46db-bb6a-e550c2216fdc.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 135 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC1369e70f-7a61-7078-e063-6394a90a9a882024-03-11WarningsExact identifier
application number: M017
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
application number: M017
Dermachange Aid Anti-ItchDIPHENHYDRAMINE HCLPrivate Label Beauty and Wellness12ed906c-d028-0ff7-e063-6394a90aaa522024-03-05WarningsExact identifier
application number: M017
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
application number: M017
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
application number: M017
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
application number: M017
Maximum Strength Scalp Itch Relief Anti-itchHYDROCORTISONERite Aid55569563-fc38-4f97-8e74-9f96e31733842024-02-28WarningsExact identifier
application number: M017
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
application number: M017
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54723-024-015472300240130 g in 1 TUBE (54723-024-01) 30 g2025-02-07NoNoCurrent