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 17 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.9487d15d-9116-4ff8-a004-ba0835ea091e2026-05-31WarningsExact identifier
application number: M017
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
application number: M017
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
application number: M017
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
application number: M017
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
application number: M017
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a054949-0889-7182-e063-6394a90aff5e2026-05-28WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
application number: M017
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
application number: M017
Equate Itch Relief GelITCH RELIEF GELWalmart, Inc7d7bb750-017e-c60e-e053-2991aa0ad6712026-05-26WarningsExact identifier
application number: M017
MyDerm Bite and StingBENZOCAINEMedline Industriesbf45c4dd-5814-4602-b96b-f82a449487632026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
Vicks VapoFreeze PAIN RELIEFCAMPHOR, MENTHOLThe Procter & Gamble Manufacturing Company526cdb40-aa65-4885-e063-6294a90afa0c2026-05-22WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact 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