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 42 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017
Maximum Strength Cortisone Cream with AloeHYDROCORTISONE CREAMCVS Pharmacyb95d30b0-6ebd-4989-a6ac-1a42e5d4aba52026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreens61b93226-10ff-43df-b1b6-bcea917a2f482026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact 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