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

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 Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui283438

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

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