FDA.reportPublic FDA data

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 64 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.97345ed4-51c3-4221-852c-2cd563f333172025-11-12WarningsExact identifier
application number: M017
ZHENG GU SHUICAMPHOR, MENTHOLGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD17552943-4f11-42d6-ad41-fbc53f2bbd9a2025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.605fc242-ad31-4aa9-bd86-fba4ddf0d3052025-11-12WarningsExact identifier
application number: M017
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact 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