ACOLYE Lidocaine Cream Topical Analgesia Cream

Product NDC
83566-617
11-digit product format
835660617
Labeler code
83566
Product ID
83566-617_57deebf7-52f2-4256-e063-6294a90a75d5
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE,MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangdong Aimu Biological Technology Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-31
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
ACOLYE Lidocaine Cream Topical Analgesia Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
250912Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57deebf7-52f1-4256-e063-6294a90a75d5Available on FDA.report

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 116 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Pain ReliefTROLAMINE SALICYLATETelebrands Corp92a29553-a102-0a0e-e053-2a95a90ab24a2024-11-20WarningsExact identifier
application number: M017
Ultra Strength Pain Relief GelMENTHOLTELEBRANDS CORPd91b2e09-550e-4968-e053-2995a90ae3232024-11-20WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief CreamLIDOCAINE 4%Telebrands Corpc3162ba8-ac2d-5a65-e053-2995a90af2462024-11-20WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain ReliefLIDOCAINETELEBRANDS CORPd91ba9b1-083f-32e9-e053-2a95a90a9bd12024-11-20WarningsExact identifier
application number: M017
DynaRubPAIN RELIEVING CREAMDynarex Corporation7f853941-a2d7-ed26-e053-2991aa0aa9ee2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsbcdc0322-bc75-4662-9c5a-d1be1d0552522024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefMENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions604a30c9-2306-47a1-bd31-94b63639dd902024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions0b489420-3b5c-43c5-aab4-0e3720acf9ce2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdd906129-a787-4352-856d-d7a915031a6e2024-11-20WarningsExact identifier
application number: M017
Walgreens Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDEWalgreens Company80d3031a-7fa9-4f5b-b85e-c7c6ef3148012024-11-20WarningsExact identifier
application number: M017
Anti-Itch Medicated Maximum StrengthBENZOCAINE AND RESORCINOLWalgreens Company7fd86dcb-edef-4d0d-b389-7ecea595fe672024-11-20WarningsExact identifier
application number: M017
Walgreens Pain ReliefBENZOCAINEWalgreens Company7cee7234-32cd-4bf3-8a6c-0882585eec7f2024-11-20WarningsExact identifier
application number: M017
Walgreens Advanced Scar GelADVANCED SCAR GELWalgreens Company2c040475-a124-485c-933e-66b452f5ab462024-11-20WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting Relief PadBENZOCAINEAcme United Corporation5087cbbd-1bbe-62ed-e054-00144ff8d46c2024-11-19WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting ReliefBENZOCAINEAcme United Corporation697127d1-c02e-16d2-e053-2a91aa0a39fd2024-11-19WarningsExact identifier
application number: M017
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving Roll-on AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.4115f0ac-e12a-4e59-94f5-a47dcc7f87662024-11-18WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83566-617-018356606170150 g in 1 JAR (83566-617-01) 50 g2026-07-31NoNoCurrent