Menthozen Hydrogel

Product NDC: 71205-334
11-digit product format: 712050334
Labeler code: 71205
Product ID: 71205-334_1cdc9d1f-d8eb-40e4-99e6-286c7dbfb986
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAPSAICIN
Dosage form: PATCH
Route: TOPICAL
Labeler: Proficient Rx LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-01
Substance: MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength: 40; .3 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Menthozen Hydrogel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/g
CAPSAICIN	.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
S07O44R1ZM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2178283	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
85a7809e-c43f-4138-a85b-44e1b586def5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-334-05	Menthozen Hydrogel	5 in 1 POUCH	PATCH	5	6
71205-334-05	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-15	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-15	Menthozen Hydrogel	15 in 1 POUCH	PATCH	15	6
71205-334-30	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-30	Menthozen Hydrogel	30 in 1 POUCH	PATCH	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-334-05	EA - Each	71205-334	8ebe78c4-2a9d-4463-8852-5899b2e17c35	1	2021-02-05
71205-334-15	EA - Each	71205-334	87828063-afb9-4749-9f52-6c85aaf0ff01	1	2019-11-12
71205-334-30	EA - Each	71205-334	18a3e94d-b288-47ef-bfdf-b0ffb7facccc	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-334	MENTHOZEN HYDROGEL (MENTHOL, CAPSAICIN) PATCH [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 6 package rows	20231207_85a7809e-c43f-4138-a85b-44e1b586def5.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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burn First Aid	BURN FIRST AID	Dynarex Corporation	826e08be-dffa-5a27-e053-2a91aa0a8701	2024-01-22	Warnings	Exact identifier application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On	MENTHOL	TARGET CORPORATION	0f95fc55-8665-9e89-e063-6394a90a7891	2024-01-22	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief Plus Menthol	LIDOCAINE, MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	77978069-a1b4-473e-83c9-8320e00eea89	2024-01-19	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMPS	CAMPHOR, MENTHOL	KOBAYASHI Healthcare International, Inc.	ba26635d-95d3-4d88-93cc-1fd4fd29fd79	2024-01-18	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	e95ebdac-9789-41c2-97da-2307e4538794	2024-01-18	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE	Unifirst First Aid Corporation	bd216f5d-f304-7d8d-e053-2a95a90aa9ce	2024-01-17	Warnings	Exact identifier application number: M017
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Exact identifier application number: M017
Pain Relief	LIDOCAINE, MENTHOL	HUMN Pharmaceuticals Inc	6c96f94a-e724-eab3-e053-2991aa0aab88	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief	LIDOCAINE	Natural Essentials, Inc.	52e82e70-53b7-4ecb-be39-fe10c94cc444	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health XL Lidocaine Pain Relief	LIDOCAINE	NATURAL ESSENTIALS, INC.	ec16da91-8244-402b-b8d8-84896094ac2c	2024-01-17	Warnings	Exact identifier application number: M017
Anti-itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Target Corporation	f444b0a6-2ed3-4236-8206-342150290675	2024-01-17	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Anti-itch	HYDROCORTISONE 1%	Target Corporation	4ff39cb8-3a20-4fe7-9829-1e882a484668	2024-01-17	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Exact identifier application number: M017
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier application number: M017
FIRST SHIELD	LIDOCAINE HCI	Ever Ready First Aid	e022bf8f-3dd8-de22-e053-2995a90a219b	2024-01-15	Warnings	Exact identifier application number: M017
Flexigen	MENTHOL 1.25%	Derma Care Research Labs, LLC	e9ae2682-59b4-e796-e053-2995a90af921	2024-01-15	Warnings	Exact identifier application number: M017
Vita-P Oral and Nasal	MENTHOL 1%	Beijing HKKY Medical Tech. Co., Ltd.	537c3843-1c92-41c6-b724-52701bbddeab	2024-01-13	Warnings	Exact identifier application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2178283	capsaicin 0.03 % / menthol 4 % Medicated Patch	PSN	85a7809e-c43f-4138-a85b-44e1b586def5	6
2178283	capsaicin 0.0003 MG/MG / menthol 0.04 MG/MG Medicated Patch	SCD	85a7809e-c43f-4138-a85b-44e1b586def5	6
2178283	capsaicin 0.03 % / menthol 4 % Medicated Patch	SY	85a7809e-c43f-4138-a85b-44e1b586def5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-334-05	71205033405	5 PATCH in 1 POUCH (71205-334-05) / 1 g in 1 PATCH	5 patch	2020-11-20	0000-00-00	No	No	Current
71205-334-15	71205033415	15 PATCH in 1 POUCH (71205-334-15) / 1 g in 1 PATCH	15 patch	2019-09-01	0000-00-00	No	No	Current
71205-334-30	71205033430	30 PATCH in 1 POUCH (71205-334-30) / 1 g in 1 PATCH	30 patch	2019-09-01	0000-00-00	No	No	Current