FDA.reportPublic FDA data

AUVON Pain Relief Roll-on

Product NDC
83391-004
11-digit product format
833910004
Labeler code
83391
Product ID
83391-004_28c4811e-8c81-4626-e063-6294a90a6bc2
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
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
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100mL
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

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
LIDOCAINE HYDROCHLORIDE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1987647

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83391-004-01AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-004-02AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-004-02AUVON Pain Relief Roll-on1 in 1 PACKAGESOLUTION12
83391-004-03AUVON Pain Relief Roll-on2 in 1 PACKAGESOLUTION22
83391-004-03AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83391-004AUVON PAIN RELIEF ROLL-ON (LIDOCAINE) SOLUTION [SHENZHEN YUWEN E-COMMERCE CO., LTD.]2Current NDC, 5 package rows20241209_8b30f623-6077-4f2e-8fa4-ce4a298953b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN8b30f623-6077-4f2e-8fa4-ce4a298953b52
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD8b30f623-6077-4f2e-8fa4-ce4a298953b52
1987647lidocaine hydrochloride 4 % Topical SolutionSY8b30f623-6077-4f2e-8fa4-ce4a298953b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83391-004-018339100040174 mL in 1 BOTTLE (83391-004-01) 74 ml2024-09-21NoNoCurrent
83391-004-02833910004021 BOTTLE in 1 PACKAGE (83391-004-02) / 74 mL in 1 BOTTLE1 bottle2024-09-21NoNoCurrent
83391-004-03833910004032 BOTTLE in 1 PACKAGE (83391-004-03) / 74 mL in 1 BOTTLE2 bottle2024-09-21NoNoCurrent