FDA.reportPublic FDA data

AUVON Pain Relief Roll-on

Product NDC
83391-003
11-digit product format
833910003
Labeler code
83391
Product ID
83391-003_28c451bc-3a8b-ae1d-e063-6294a90ad61c
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SHENZHEN YUWEN E-COMMERCE CO., LTD.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-21
Substance
MENTHOL
Active strength
4 g/100mL
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
AUVON Pain Relief Roll-on
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283438Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df239c4d-af6a-41ca-baed-d0788782ce9fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83391-003-01AUVON Pain Relief Roll-on1 in 1 PACKAGESOLUTION12
83391-003-01AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-02AUVON Pain Relief Roll-on2 in 1 PACKAGESOLUTION22
83391-003-02AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-03AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-03AUVON Pain Relief Roll-on3 in 1 PACKAGESOLUTION32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83391-003AUVON PAIN RELIEF ROLL-ON (MENTHOL) SOLUTION [SHENZHEN YUWEN E-COMMERCE CO., LTD.]2Current NDC, 6 package rows20241209_df239c4d-af6a-41ca-baed-d0788782ce9f.zip

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 92 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Ultra OTC Strength Pain Relief CreamCAMPHOR, MENTHOL, AND METHYL SALICYLATEVeridian Healthcare36c3bbf9-a559-4c0d-e063-6394a90a8a1a2025-06-04WarningsExact identifier
application number: M017
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
application number: M017
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
application number: M017
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsExact identifier
application number: M017
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
application number: M017
PAIN NO MORE THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.f7bacc8e-6a8b-4cd8-bd0e-68890bee58182025-05-29WarningsExact identifier
application number: M017
DermaD ANTI-ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.8f4a57cb-0a5b-42b0-a325-1f92f3942ad92025-05-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.f7aecfb4-c194-4554-8d05-4e46005e654b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.b679ed7b-9d88-4eff-9743-567affe0fe2b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll OnMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.28eb8273-5789-4f33-bbbe-3a5ec7bc79292025-05-27WarningsExact identifier
application number: M017
AUVON Pain Relief CreamLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.358c2632-3b90-1c54-e063-6294a90ad4612025-05-22WarningsExact identifier
application number: M017
WelAhead by Welmate Lidocaine 5% Roll-onLIDOCAINE 5%OTC PHARM LLC0b75e83e-8c7b-6247-e063-6294a90ac4132025-05-21WarningsExact identifier
application number: M017
Bliss RepublicLIDOCAINE NUMBING EXTRA STRENGTH CREAMSargass Group Limited Liability Company35aba13a-95e6-a395-e063-6294a90a5bdc2025-05-21WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporatione911478f-7153-4700-b945-92ec54972f452025-05-21WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHPreferred Pharmaceuticals Inc.0976a898-8d79-4b85-b473-c8ad32b4fd002025-05-20WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283438menthol 4 % Topical SolutionPSNdf239c4d-af6a-41ca-baed-d0788782ce9f2
283438menthol 40 MG/ML Topical SolutionSCDdf239c4d-af6a-41ca-baed-d0788782ce9f2
283438menthol 4 % Topical SolutionSYdf239c4d-af6a-41ca-baed-d0788782ce9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83391-003-01833910003011 BOTTLE in 1 PACKAGE (83391-003-01) / 74 mL in 1 BOTTLE1 bottle2024-09-21NoNoCurrent
83391-003-02833910003022 BOTTLE in 1 PACKAGE (83391-003-02) / 74 mL in 1 BOTTLE2 bottle2024-09-21NoNoCurrent
83391-003-03833910003033 BOTTLE in 1 PACKAGE (83391-003-03) / 74 mL in 1 BOTTLE3 bottle2024-09-21NoNoCurrent