FDA.reportPublic FDA data

Aruba Aloe Alcoholada

Product NDC
53675-212
11-digit product format
536750212
Labeler code
53675
Product ID
53675-212_3bc81f57-d185-ecb6-e063-6394a90a29e3
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-15
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 mg/mL
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
Aruba Aloe Alcoholada
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/mL

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
f56c62b0-75db-4499-858e-54e10b0e140aAvailable 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
53675-212-00Aruba Aloe Alcoholada251 mL in 1 TUBECREAM2512

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 99 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
application number: M017
Thunder Fck Male Genital DesensitizerBENZOCAINEPRODUCT MAX GROUP INC93188a42-0d3c-4159-bdc7-bbc5ec5c67442025-03-06WarningsExact identifier
application number: M017
Body Action Climax Guard DelayBENZOCAINEPRODUCT MAX GROUP INCf88e0b42-974e-4f46-a93b-34b06320770a2025-03-06WarningsExact identifier
application number: M017
XENCARE INFLAMAX NATURAL TOPICAL PAINMENTHOL, CAPSAICINXenex Laboratories Inc.25b9621b-3c16-3cb9-e063-6294a90ab5982025-03-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY1cd37b69-2cfb-130d-e063-6394a90af50b2025-03-06WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Co.c22bba5c-bb6f-494e-987a-f6e36c1b48932025-03-06WarningsExact identifier
application number: M017
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
application number: M017
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
application number: M017
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.fb89dca6-c0c0-4092-b3f5-e59c956c3d6c2025-03-04WarningsExact identifier
application number: M017
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
application number: M017
Thera Plus Pain Relief Arthritis and MuscleCAPSAICINFOURSTAR GROUP USA, INC.dcff0a2d-7190-4b0c-abde-ba009b8ef0052025-02-28WarningsExact identifier
application number: M017
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
application number: M017
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
application number: M017
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-212-0053675021200251 mL in 1 TUBE (53675-212-00) 251 ml2025-06-15NoNoCurrent