MENTHOL 5%

Product NDC: 85096-301
11-digit product format: 850960301
Labeler code: 85096
Product ID: 85096-301_30916d71-bf2f-1bc0-e063-6394a90ab033
Type: HUMAN OTC DRUG
Nonproprietary name: menthol 5%
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Marcella Health
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-03-14
Substance: MENTHOL, (+)-
Active strength: 500 mg/10g
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: MENTHOL 5%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, (+)-	500 mg/10g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C6B1OE8P3W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
420222	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
30914c0a-fbda-5674-e063-6294a90aba5b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85096-301-01	MENTHOL 5%	11 g in 1 PATCH	PATCH	11		1
85096-301-30	MENTHOL 5%	30 in 1 BOX	PATCH	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85096-301-30	EA - Each	85096-301	ecbae30c-0754-4262-b419-113c589dd638	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85096-301	MENTHOL 5% PATCH [MARCELLA HEALTH]	1	Current NDC, 2 package rows	20250321_30914c0a-fbda-5674-e063-6294a90aba5b.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 99 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	Warnings	Exact identifier application number: M017
Signature Care Medicated Pain Relief Patch	LIDOCAINE	Safeway, Inc.	2165a342-5f8b-78e0-e063-6394a90a06c4	2025-02-12	Warnings	Exact identifier application number: M017
CheeZheng Pain Relieveing Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd.	abcebdf1-9037-4094-93e1-ce8f20b18ea7	2025-02-11	Warnings	Exact identifier application number: M017
Tibetree Pain Relieveing Medicated Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	4216bd48-5c62-4e87-adcc-67bf7152d64d	2025-02-11	Warnings	Exact identifier application number: M017
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Olakino Therapeutics LLC	2a41a621-c6f7-5819-e063-6394a90ae67d	2025-02-07	Warnings	Exact identifier application number: M017
Pain Reliveing Patch	LIDOCAINE 4%	simple diagnostics	02ed0b27-bba9-ec0c-e063-6294a90a014d	2025-02-07	Warnings	Exact identifier application number: M017
FlexDermal Pain Relieving Roll-On	MENTHOL	SOLVADERM LLC	d4d8050e-0761-4491-8635-39c806701eb5	2025-02-06	Warnings	Exact identifier application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine	LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE	Clarion Brands LLC	2d7e9f6a-0f21-b103-e063-6294a90a912f	2025-02-06	Warnings	Exact identifier application number: M017
signature care Hydrocortisone	HYDROCORTISONE	Safeway	9fe16fc5-77e3-47f5-a943-85bc6565c0d4	2025-02-06	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	2d685602-5cd6-3b36-e063-6394a90a3c5d	2025-02-05	Warnings	Exact identifier application number: M017
Lidocore	LIDOCAINE	iON Pharma, LLC	204c3e50-1ac8-f442-e063-6294a90ae7b5	2025-02-05	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C6B1OE8P3W	MENTHOL, (+)-	15356-60-2	MENTHOL, (+)-

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
420222	menthol 5 % Medicated Patch	PSN	30914c0a-fbda-5674-e063-6294a90aba5b	1
420222	menthol 5 % Medicated Patch	PSN	3bdd0c52-29d8-ab67-e063-6294a90a9c45	1
420222	menthol 0.05 MG/MG Medicated Patch	SCD	30914c0a-fbda-5674-e063-6294a90aba5b	1
420222	menthol 0.05 MG/MG Medicated Patch	SCD	3bdd0c52-29d8-ab67-e063-6294a90a9c45	1
420222	menthol 5 % Medicated Patch	SY	30914c0a-fbda-5674-e063-6294a90aba5b	1
420222	menthol 5 % Medicated Patch	SY	3bdd0c52-29d8-ab67-e063-6294a90a9c45	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85096-301-01	85096030101	11 g in 1 PATCH	11 g				Historical
85096-301-30	85096030130	30 PATCH in 1 BOX (85096-301-30) / 11 g in 1 PATCH (85096-301-01)	30 patch	2025-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Menthol Patch Menthol 5% \| Pain Relieving Patch	Advanced Rx of Tennessee, LLC	2025-08-08	HUMAN OTC DRUG LABEL	1
Menthol Patch Menthol 5% \| Pain Relieving Patch	Marcella Health	2025-03-14	HUMAN OTC DRUG LABEL	1