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
Ingredient	Strength
MENTHOL	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
df239c4d-af6a-41ca-baed-d0788782ce9f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83391-003-01	AUVON Pain Relief Roll-on	1 in 1 PACKAGE	SOLUTION	1	2
83391-003-01	AUVON Pain Relief Roll-on	74 mL in 1 BOTTLE	SOLUTION	74	2
83391-003-02	AUVON Pain Relief Roll-on	2 in 1 PACKAGE	SOLUTION	2	2
83391-003-02	AUVON Pain Relief Roll-on	74 mL in 1 BOTTLE	SOLUTION	74	2
83391-003-03	AUVON Pain Relief Roll-on	74 mL in 1 BOTTLE	SOLUTION	74	2
83391-003-03	AUVON Pain Relief Roll-on	3 in 1 PACKAGE	SOLUTION	3	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83391-003	AUVON PAIN RELIEF ROLL-ON (MENTHOL) SOLUTION [SHENZHEN YUWEN E-COMMERCE CO., LTD.]	2	Current NDC, 6 package rows	20241209_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 135 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283438	menthol 4 % Topical Solution	PSN	df239c4d-af6a-41ca-baed-d0788782ce9f	2
283438	menthol 40 MG/ML Topical Solution	SCD	df239c4d-af6a-41ca-baed-d0788782ce9f	2
283438	menthol 4 % Topical Solution	SY	df239c4d-af6a-41ca-baed-d0788782ce9f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83391-003-01	83391000301	1 BOTTLE in 1 PACKAGE (83391-003-01) / 74 mL in 1 BOTTLE	1 bottle	2024-09-21	No	No	Current
83391-003-02	83391000302	2 BOTTLE in 1 PACKAGE (83391-003-02) / 74 mL in 1 BOTTLE	2 bottle	2024-09-21	No	No	Current
83391-003-03	83391000303	3 BOTTLE in 1 PACKAGE (83391-003-03) / 74 mL in 1 BOTTLE	3 bottle	2024-09-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
83391-003 Menthol Pain Relief Roll-on	SHENZHEN YUWEN E-COMMERCE CO., LTD.	2024-12-08	HUMAN OTC DRUG LABEL	2